The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-ohmeda Tec 6 Plus Nad Variant Anesthesia.
Device ID | K000275 |
510k Number | K000275 |
Device Name: | DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Daniel Kosednar |
Correspondent | Daniel Kosednar DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-31 |
Decision Date | 2000-04-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682112536 | K000275 | 000 |
00840682112789 | K000275 | 000 |
00840682112659 | K000275 | 000 |