The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Solaris Compatible Reusable Adult Spo2 Finger Sensors, Models S100a-090103 And 300103, S200a-090101 And 300101.
| Device ID | K061931 |
| 510k Number | K061931 |
| Device Name: | SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 |
| Classification | Oximeter |
| Applicant | SOLARIS MEDICAL TECHNOLOGY, INC. 2355 EAST FLAMINGO ROAD SUITE 201 G Las Vegas, NV 89119 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SOLARIS MEDICAL TECHNOLOGY, INC. 2355 EAST FLAMINGO ROAD SUITE 201 G Las Vegas, NV 89119 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-07 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06900234100054 | K061931 | 000 |
| 06900234100047 | K061931 | 000 |