The following data is part of a premarket notification filed by Anetec, Inc. with the FDA for Transparent Anesthesia Filter.
Device ID | K944189 |
510k Number | K944189 |
Device Name: | TRANSPARENT ANESTHESIA FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | ANETEC, INC. 340 BELL BLVD. Belleville, Ontario, CA K8p 5h7 |
Contact | Catharine P Huff |
Correspondent | Catharine P Huff ANETEC, INC. 340 BELL BLVD. Belleville, Ontario, CA K8p 5h7 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-17 |
Decision Date | 1994-10-28 |