The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Data Storage Spirometer.
| Device ID | K930085 |
| 510k Number | K930085 |
| Device Name: | VITALOGRAPH DATA STORAGE SPIROMETER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Phil Hemes |
| Correspondent | Phil Hemes VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-07 |
| Decision Date | 1993-07-26 |