The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Olympus Endoscopic Flushing Pump Model Ofp-1.
| Device ID | K000948 |
| 510k Number | K000948 |
| Device Name: | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-23 |
| Decision Date | 2000-05-12 |