The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Disposable Bacteriological Filter.
Device ID | K942779 |
510k Number | K942779 |
Device Name: | DISPOSABLE BACTERIOLOGICAL FILTER |
Classification | Spirometer, Diagnostic |
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 | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-13 |
Decision Date | 1994-07-13 |