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 |