The following data is part of a premarket notification filed by Medical Industrial Equipment with the FDA for Vapamasta 6.
Device ID | K980489 |
510k Number | K980489 |
Device Name: | VAPAMASTA 6 |
Classification | Vaporizer, Anesthesia, Non-heated |
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 | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-09 |
Decision Date | 1998-08-31 |