The following data is part of a premarket notification filed by Amemo Inc with the FDA for Fingertip Pulse Oximeter A310.
| Device ID | K153021 |
| 510k Number | K153021 |
| Device Name: | Fingertip Pulse Oximeter A310 |
| Classification | Oximeter |
| Applicant | AMEMO INC 1154 CADILLAC COURT Milpitas, CA 95035 |
| Contact | Hua Xie |
| Correspondent | Hua Xie AMEMO INC 1154 CADILLAC COURT Milpitas, CA 95035 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859811007391 | K153021 | 000 |
| 36947832500030 | K153021 | 000 |
| 00860002308203 | K153021 | 000 |