The following data is part of a premarket notification filed by General Anaesthetic Services Limited with the FDA for Gav - General Anaesthetic Vaporizer.
Device ID | K051666 |
510k Number | K051666 |
Device Name: | GAV - GENERAL ANAESTHETIC VAPORIZER |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | GENERAL ANAESTHETIC SERVICES LIMITED INGROW BRIDGE BUSINESS PARK HALIFAX ROAD Keighley, West Yorkshire, GB Bd21 5ef |
Contact | Andrew Jw Wall |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-06-22 |
Decision Date | 2005-08-23 |
Summary: | summary |