The following data is part of a premarket notification filed by Delbio Incorporated with the FDA for Oxicare Fingertip Pulse Oximeter.
| Device ID | K122927 |
| 510k Number | K122927 |
| Device Name: | OXICARE FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | DELBIO INCORPORATED 3F & 6F, NO 252 SHANGYING ROAD TAOYUAN COUNTY Guishan Industrial Zone, TW 33341 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan DELBIO INCORPORATED 3F & 6F, NO 252 SHANGYING ROAD TAOYUAN COUNTY Guishan Industrial Zone, TW 33341 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2012-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713072980748 | K122927 | 000 |
| 04713072981554 | K122927 | 000 |
| 04713072981547 | K122927 | 000 |