The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Timox Oxygen Timer.
Device ID | K920360 |
510k Number | K920360 |
Device Name: | TIMOX OXYGEN TIMER |
Classification | Transducer, Gas Flow |
Applicant | MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | John R Selady |
Correspondent | John R Selady MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BXP |
CFR Regulation Number | 868.2885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-27 |
Decision Date | 1992-08-03 |