The following data is part of a premarket notification filed by Clover Medical Equipment Services, Inc. with the FDA for Tec Iv And Tec V Anesthesia Vaporizers For Sevoflurane.
Device ID | K952083 |
510k Number | K952083 |
Device Name: | TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | CLOVER MEDICAL EQUIPMENT SERVICES, INC. 172 HOLTZ DR. Buffalo, NY 14225 |
Contact | Ronald Luich |
Correspondent | Ronald Luich CLOVER MEDICAL EQUIPMENT SERVICES, INC. 172 HOLTZ DR. Buffalo, NY 14225 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-03 |
Decision Date | 1996-10-21 |