The following data is part of a premarket notification filed by Cardio-search Ltd. with the FDA for Flowmeter Nipple Adaptor.
| Device ID | K934945 |
| 510k Number | K934945 |
| Device Name: | FLOWMETER NIPPLE ADAPTOR |
| Classification | Flowmeter, Nonback-pressure Compensated, Bourdon Gauge |
| Applicant | CARDIO-SEARCH LTD. 170 OLD GUELPH ROAD Dundas, Ont.l9h 5y2, Canada, CA |
| Product Code | CCN |
| CFR Regulation Number | 868.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-13 |
| Decision Date | 1993-11-17 |