The following data is part of a premarket notification filed by Neoprobe Corp. with the FDA for Quantix/or Blood Flow Monitor; Flexible Probe With Optional Vessel Stabilizer.
| Device ID | K050088 |
| 510k Number | K050088 |
| Device Name: | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin, OH 43017 |
| Contact | Rodger A Brown |
| Correspondent | Rodger A Brown NEOPROBE CORP. 425 METRO PLACE NORTH, STE. 300 Dublin, OH 43017 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-13 |
| Decision Date | 2005-02-08 |
| Summary: | summary |