TELEPACK-608,PANORAMA,DOMESTIC
The Panorama Telepack-608 is a battery-powered ambulatory monitoring unit for hospital or clinical use. It sends patient physiological data to the Panorama Telemetry System so clinicians…
The Panorama Telepack-608 is a battery-powered ambulatory monitoring unit for hospital or clinical use. It sends patient physiological data to the Panorama Telemetry System so clinicians can monitor a patient while the patient remains mobile within the system’s defined coverage area.
The unit communicates using Wireless Medical Telemetry Service radio transmission. The Panorama network routes the received data to its central station, where it can be displayed, trended, stored and printed.
Network Use
The Telepack is one component of the Panorama Patient Monitoring Network. Use of the network is under the direct supervision of a licensed healthcare practitioner.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K150082 |
| Record published | 2016-09-23 |
| Record revised | 2020-02-06 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0161F-01000-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260098 | 2026-05-20 |
| K253170 | 2026-04-16 |
| K213799 | 2022-07-12 |
| K202405 | 2021-01-07 |
| K200015 | 2020-06-08 |
| K192972 | 2020-05-07 |
| K191769 | 2019-10-31 |
| K190011 | 2019-07-10 |
| K182075 | 2018-12-10 |
| K171901 | 2017-11-15 |
| K170876 | 2017-08-23 |
| K153448 | 2016-03-03 |
| K152902 | 2016-02-18 |
| K150082 | 2015-09-02 |
| K150352 | 2015-09-02 |
| K142601 | 2014-11-14 |
| K123074 | 2013-07-03 |
| K092449 | 2010-08-30 |
| K073280 | 2008-06-23 |
| K072346 | 2007-11-29 |
| K070791 | 2007-06-26 |
| K062194 | 2007-04-11 |
| K060281 | 2006-06-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mindray DS USA, Inc. | 510(k) number | 2015-12-15 | Class II | Software design | An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations ar | 63 products | 2017-03-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.