The following data is part of a premarket notification filed by Aristo Medical with the FDA for Comsat Adult,pediatric,infant,neonatal,disposable Sensor/comsat Reusable Finger Sensor.
| Device ID | K970769 |
| 510k Number | K970769 |
| Device Name: | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR |
| Classification | Oximeter |
| Applicant | ARISTO MEDICAL P.O. BOX 1637 Waukesha, WI 53187 -1637 |
| Contact | Larry Lepley |
| Correspondent | Larry Lepley ARISTO MEDICAL P.O. BOX 1637 Waukesha, WI 53187 -1637 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-08-28 |