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 |