The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Vitalograph Micro.
| Device ID | K991412 |
| 510k Number | K991412 |
| Device Name: | VITALOGRAPH MICRO |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Phil Hemes |
| Correspondent | Phil Hemes 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 | 1999-04-23 |
| Decision Date | 2000-02-04 |