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 |