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 |