The following data is part of a premarket notification filed by Optical Sensors, Inc. with the FDA for Sensilase Pad 3000.
| Device ID | K040654 |
| 510k Number | K040654 |
| Device Name: | SENSILASE PAD 3000 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring OPTICAL SENSORS, INC. 800 LENANGER LN. Stoughton, WI 53589 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-12 |
| Decision Date | 2004-06-04 |
| Summary: | summary |