The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Power Infuser, Model M100b-3a.
| Device ID | K090736 |
| 510k Number | K090736 |
| Device Name: | POWER INFUSER, MODEL M100B-3A |
| Classification | Pump, Infusion |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA |
| Contact | Eileen M Boyle |
| Correspondent | Eileen M Boyle ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-19 |
| Decision Date | 2009-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946021603 | K090736 | 000 |
| 00847946021597 | K090736 | 000 |