The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Spirotrac Iii.
| Device ID | K912412 |
| 510k Number | K912412 |
| Device Name: | VITALOGRAPH SPIROTRAC III |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Peter Mitchell |
| Correspondent | Peter Mitchell VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-10-15 |