The following data is part of a premarket notification filed by Mays And Associates, Inc. with the FDA for Omnipro System.
| Device ID | K050143 |
| 510k Number | K050143 |
| Device Name: | OMNIPRO SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | MAYS AND ASSOCIATES, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | Harvey Knauss |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B62571884000 | K050143 | 000 |
| B62571883000 | K050143 | 000 |
| B62536084100 | K050143 | 000 |
| B62536084000 | K050143 | 000 |
| B62536083000 | K050143 | 000 |