Welch Allyn, Inc.
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No…
RScribe 12-Lead Multi-Channel Electrocardiograph – version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Beijing (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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| DM Systems (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K043010 |
| Record published | 2019-07-01 |
| Record revised | 2025-02-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2021-09-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901006 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901006 | In distribution | |
| 901142 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901006 | In distribution | |
| 901141 | In distribution | |
| 901142 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901141 | In distribution | |
| 901127 | In distribution | |
| 901141 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 60 |
| Norav NR Series | Norav Medical Inc. | 56 |
| Eclipse Pro | Spacelabs Healthcare (Washington), Inc | 25 |
| Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 15 |
| Seer 1000 ECG Cable | Getemed Medizin- UND Informationstechnik AG | 12 |
| ECG Cable for Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 12 |
| Seer | Suzuken Co., Ltd. | 12 |
| H12+ | Mortara Instrument, Inc. | 10 |
| Lifecard | Spacelabs Healthcare (Washington), Inc | 10 |
| H3+ Patient Cable | Mortara Instrument, Inc. | 10 |
| Spiderview | Microport CRM SRL | 9 |
| ECG Cable for CM 3000-12 BT / Seer 12 | Getemed Medizin- UND Informationstechnik AG | 7 |
Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)
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.