The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Index 2e, Index 2f, Index 2ef, Cardiosat 100e, Cardiosat 100f, Cardiosat 100ef.
Device ID | K971273 |
510k Number | K971273 |
Device Name: | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF |
Classification | Oximeter |
Applicant | BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
Contact | Michael N Sevigny |
Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-07 |
Decision Date | 1997-10-08 |
Summary: | summary |