The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitapep.
| Device ID | K844963 |
| 510k Number | K844963 |
| Device Name: | VITAPEP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Lovina G Freeman |
| Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-24 |
| Decision Date | 1985-06-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITAPEP 87007389 5277420 Live/Registered |
Big V Feeds, Inc. 2016-04-20 |