The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll R Series With Nibp And Etco2 Options, Zoll R Series.
| Device ID | K090989 |
| 510k Number | K090989 |
| Device Name: | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Charles W Kolifrath |
| Correspondent | Charles W Kolifrath ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRM |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946021672 | K090989 | 000 |
| 00847946021269 | K090989 | 000 |
| 00847946024215 | K090989 | 000 |