The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Nellcor Compatible Reusable Spo2 Soft-finger Sensor, Model T100a-090103.
| Device ID | K100077 |
| 510k Number | K100077 |
| Device Name: | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 |
| Classification | Oximeter |
| Applicant | SOLARIS MEDICAL TECHNOLOGY, INC. 400 OYSTER POINT BLVD. SUITE 534 South San Francisco, CA 94080 |
| Contact | Rachel Cheng |
| Correspondent | Rachel Cheng SOLARIS MEDICAL TECHNOLOGY, INC. 400 OYSTER POINT BLVD. SUITE 534 South San Francisco, CA 94080 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817698020186 | K100077 | 000 |
| 56900234150115 | K100077 | 000 |
| 06900234100108 | K100077 | 000 |
| 56900234100097 | K100077 | 000 |
| 56900234100080 | K100077 | 000 |
| 06900234100207 | K100077 | 000 |
| 06900234100191 | K100077 | 000 |
| 06900234100177 | K100077 | 000 |
| 06900234100245 | K100077 | 000 |
| 10817698020312 | K100077 | 000 |
| 10817698020268 | K100077 | 000 |
| 56900234150221 | K100077 | 000 |
| 07290013819260 | K100077 | 000 |
| 07290013819277 | K100077 | 000 |
| 00817698020179 | K100077 | 000 |
| 00817698020162 | K100077 | 000 |
| 00817698020155 | K100077 | 000 |
| 00817698020148 | K100077 | 000 |
| 00817698020124 | K100077 | 000 |
| 00817698020117 | K100077 | 000 |
| 00817698020100 | K100077 | 000 |
| 00817698020094 | K100077 | 000 |
| 00817698020087 | K100077 | 000 |
| 07290013819284 | K100077 | 000 |
| 10817698020220 | K100077 | 000 |