The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Diss Female Air Adaptor.
Device ID | K813235 |
510k Number | K813235 |
Device Name: | DISS FEMALE AIR ADAPTOR |
Classification | Tent, Oxygen, Electrically Powered |
Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYK |
CFR Regulation Number | 868.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-17 |
Decision Date | 1981-12-08 |