The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Bp Pump.
| Device ID | K921074 |
| 510k Number | K921074 |
| Device Name: | BP PUMP |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-06 |
| Decision Date | 1992-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007201 | K921074 | 000 |
| 00850540007195 | K921074 | 000 |