The following data is part of a premarket notification filed by Premier Anesthesia Systems with the FDA for Idacare Anesthesia Management Workstatin.
Device ID | K930492 |
510k Number | K930492 |
Device Name: | IDACARE ANESTHESIA MANAGEMENT WORKSTATIN |
Classification | Gas-machine, Anesthesia |
Applicant | PREMIER ANESTHESIA SYSTEMS 1050 CONNECTICUT AVE.,N.W. Washington, DC 20036 |
Contact | Wayne Matelski |
Correspondent | Wayne Matelski PREMIER ANESTHESIA SYSTEMS 1050 CONNECTICUT AVE.,N.W. Washington, DC 20036 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1993-06-18 |