The following data is part of a premarket notification filed by Q Core Medical Ltd with the FDA for Sapphire Infusion Pump.
| Device ID | K123049 |
| 510k Number | K123049 |
| Device Name: | SAPPHIRE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | Q CORE MEDICAL LTD 12154 DARNESTOWN ROAD #236 Gaitherburg, MD 20878 |
| Contact | Rhona Shanker |
| Correspondent | Rhona Shanker Q CORE MEDICAL LTD 12154 DARNESTOWN ROAD #236 Gaitherburg, 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 | 2012-09-28 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290109150547 | K123049 | 000 |
| 07290109150109 | K123049 | 000 |
| 07290109150000 | K123049 | 000 |
| 27290109150103 | K123049 | 000 |
| 07290109150086 | K123049 | 000 |
| 07290109150024 | K123049 | 000 |
| 27290109150004 | K123049 | 000 |
| 27290109159311 | K123049 | 000 |
| 27290109159267 | K123049 | 000 |
| 27290109159274 | K123049 | 000 |
| 27290109159250 | K123049 | 000 |
| 27290109159229 | K123049 | 000 |
| 07290109150147 | K123049 | 000 |
| 07290109150093 | K123049 | 000 |
| 07290109150055 | K123049 | 000 |
| 27290109150530 | K123049 | 000 |
| 27290109150523 | K123049 | 000 |
| 27290109150516 | K123049 | 000 |
| 27290109150424 | K123049 | 000 |
| 27290109150417 | K123049 | 000 |
| 27290109150400 | K123049 | 000 |
| 27290109150394 | K123049 | 000 |
| 27290109150332 | K123049 | 000 |
| 27290109150325 | K123049 | 000 |
| 07290109150277 | K123049 | 000 |
| 07290109150031 | K123049 | 000 |
| 27290109159205 | K123049 | 000 |