The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Medipalm-20.
| Device ID | K031202 |
| 510k Number | K031202 |
| Device Name: | MEDIPALM-20 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | BRAEBON MEDICAL CORP. 120 WALGREEN DR (RR#3) SUITE #1 Carp, Ontario, CA K0a 1l0 |
| Contact | Richard A Bonato |
| 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 | 2003-04-16 |
| Decision Date | 2003-05-01 |
| Summary: | summary |