The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Escort Spirometer.
| Device ID | K925085 |
| 510k Number | K925085 |
| Device Name: | ESCORT SPIROMETER |
| Classification | Spirometer, Diagnostic |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Phillip Hemes |
| Correspondent | Phillip Hemes 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 | 1992-10-07 |
| Decision Date | 1993-08-12 |