The following data is part of a premarket notification filed by Q Core Medical Ltd with the FDA for Sapphire Infusion Pump.
| Device ID | K141389 |
| 510k Number | K141389 |
| Device Name: | SAPPHIRE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | Q CORE MEDICAL LTD 12154 DARNESTOWN ROAD #236 Gaithersburg, MD 20878 |
| Contact | Rhona Shanker |
| Correspondent | Rhona Shanker Q CORE MEDICAL LTD 12154 DARNESTOWN ROAD #236 Gaithersburg, MD 20878 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290109150462 | K141389 | 000 |
| 27290109159243 | K141389 | 000 |
| 27290109159304 | K141389 | 000 |
| 27290109159199 | K141389 | 000 |
| 27290109159281 | K141389 | 000 |
| 27290109159298 | K141389 | 000 |
| 07290109150079 | K141389 | 000 |
| 07290109150161 | K141389 | 000 |
| 27290109150349 | K141389 | 000 |
| 27290109150356 | K141389 | 000 |
| 27290109150431 | K141389 | 000 |
| 27290109150448 | K141389 | 000 |
| 27290109150455 | K141389 | 000 |
| 17290109159215 | K141389 | 000 |