The following data is part of a premarket notification filed by Medical Industrial Equipment with the FDA for Hawk Anaesthesia Induction Unit.
Device ID | K981845 |
510k Number | K981845 |
Device Name: | HAWK ANAESTHESIA INDUCTION UNIT |
Classification | Gas-machine, Anesthesia |
Applicant | MEDICAL INDUSTRIAL EQUIPMENT FALCON RD SOWTON INDUSTRIAL ESTATE Exeter, Devon, GB Ex2 7na |
Contact | Henry Marshall |
Correspondent | Henry Marshall MEDICAL INDUSTRIAL EQUIPMENT FALCON RD SOWTON INDUSTRIAL ESTATE Exeter, Devon, GB Ex2 7na |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-26 |
Decision Date | 1998-11-03 |