The following data is part of a premarket notification filed by Delbio Incorporation with the FDA for Oxicare Fingertip Pulse Oximeter.
| Device ID | K133090 |
| 510k Number | K133090 |
| Device Name: | OXICARE FINGERTIP PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | DELBIO INCORPORATION 4405 CUSHING PKWY. Fremont City, CA 94538 |
| Contact | Erica Li |
| Correspondent | Erica Li DELBIO INCORPORATION 4405 CUSHING PKWY. Fremont City, CA 94538 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713072980786 | K133090 | 000 |