The following data is part of a premarket notification filed by Aristo Medical Products, Inc. with the FDA for Comsat Adult,pediatric,infant,neonatal Disposable Sensor And Comsat Reusable Finger Sensor.
| Device ID | K960251 |
| 510k Number | K960251 |
| Device Name: | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR |
| Classification | Oximeter |
| Applicant | ARISTO MEDICAL PRODUCTS, INC. 407 PILOT CT., #400-A Waukesha, WI 53188 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski ARISTO MEDICAL PRODUCTS, INC. 407 PILOT CT., #400-A Waukesha, WI 53188 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-18 |
| Decision Date | 1996-03-26 |