The following data is part of a premarket notification filed by Eagle Medical Equipment Co. with the FDA for Accupulse Pulse Oximeter.
| Device ID | K062724 |
| 510k Number | K062724 |
| Device Name: | ACCUPULSE PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | EAGLE MEDICAL EQUIPMENT CO. 537 N SPENCER Mesa, AZ 85203 |
| Contact | James A Dunning |
| Correspondent | James A Dunning EAGLE MEDICAL EQUIPMENT CO. 537 N SPENCER Mesa, AZ 85203 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-12 |
| Decision Date | 2007-05-11 |
| Summary: | summary |