The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda - Low Flow Flowmeter.
| Device ID | K910316 |
| 510k Number | K910316 |
| Device Name: | OHMEDA - LOW FLOW FLOWMETER |
| Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | CAX |
| CFR Regulation Number | 868.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1991-04-12 |