R Series
Defibrillator ,MAIN,ALS,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBP,CF/USB,R SERIES, JAPAN
2manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | DRO |
| Device type | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K990762 |
| Record published | 2015-10-23 |
| Record revised | 2026-02-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure from 0 KiloPascal; Handling environment temperature 0 to 55 °C; Storage environment humidity 5 to 95 % RH |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30000003101130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001010011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001005201310362 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 30001009201210362 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 30001009201310363 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M Series Biphasic | Zoll Medical Corporation | 97 |
| Defibrillation Electrodes | TZ Medical, Inc. | 31 |
| Medi-Trace Cadence | Cardinal Health | 17 |
| Kendall | Cardinal Health | 5 |
| HeartStart | Philips Medical Systems Hsg | 2 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Philips Medical Systems Hsg | 2 |
| PAD 3020-XLT | TZ Medical, Inc. | 1 |
| Pedi-Padz | Zoll Medical Corporation | 1 |
| PAD 1115Z | TZ Medical, Inc. | 1 |
| Pad 101NHK | TZ Medical, Inc. | 1 |
| PAD 1114 | TZ Medical, Inc. | 1 |
| PAD 3020-HP | TZ Medical, Inc. | 1 |
Showing 12 of 36. All products under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950856 | 1995-12-29 |
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.