The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Bio-probe(r) Blood Flow Monitoring Syst(tx-50/50p).
| Device ID | K924208 |
| 510k Number | K924208 |
| Device Name: | BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169878167 | K924208 | 000 |
| 00643169315761 | K924208 | 000 |
| 00681490409254 | K924208 | 000 |
| 00681490409209 | K924208 | 000 |
| 00681490409186 | K924208 | 000 |
| 00673978170640 | K924208 | 000 |
| 00673978169903 | K924208 | 000 |
| 00673978166933 | K924208 | 000 |
| 00673978166926 | K924208 | 000 |
| 00763000044077 | K924208 | 000 |
| 00643169315778 | K924208 | 000 |
| 00643169315785 | K924208 | 000 |
| 00643169315792 | K924208 | 000 |
| 00643169878150 | K924208 | 000 |
| 00643169858909 | K924208 | 000 |
| 00643169858893 | K924208 | 000 |
| 00643169858886 | K924208 | 000 |
| 00643169858879 | K924208 | 000 |
| 00643169858862 | K924208 | 000 |
| 00643169858855 | K924208 | 000 |
| 00643169315815 | K924208 | 000 |
| 00643169315808 | K924208 | 000 |
| 00763000044060 | K924208 | 000 |