The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Penlon Ppv Vaporizer.
Device ID | K844007 |
510k Number | K844007 |
Device Name: | PENLON PPV VAPORIZER |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | PENLON, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
Contact | Wond |
Correspondent | Wond PENLON, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-12 |
Decision Date | 1985-03-12 |