The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Ida-4 And Ipt-mc.
| Device ID | K973609 |
| 510k Number | K973609 |
| Device Name: | IDA-4 AND IPT-MC |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-12-18 |
| Summary: | summary |