The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Vitalograph Model 2120.
| Device ID | K946075 |
| 510k Number | K946075 |
| Device Name: | VITALOGRAPH MODEL 2120 |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Gary Casey |
| Correspondent | Gary Casey VITALOGRAPH, INC. 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 | 1994-12-05 |
| Decision Date | 1995-08-04 |