The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Electronic Flow Meter.
| Device ID | K943678 |
| 510k Number | K943678 |
| Device Name: | ELECTRONIC FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Alan Dunne |
| Correspondent | Alan Dunne VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1995-12-14 |