The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Nightron Polysomnography System.
| Device ID | K022249 |
| 510k Number | K022249 |
| Device Name: | NIGHTRON POLYSOMNOGRAPHY SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | TELEDIAGNOSTIC SYSTEMS, INC. 1757 EAST BAYSHORE RD., #24 Redwood City, CA 94063 -4151 |
| Contact | Larry Woodard |
| Correspondent | Larry Woodard TELEDIAGNOSTIC SYSTEMS, INC. 1757 EAST BAYSHORE RD., #24 Redwood City, CA 94063 -4151 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2002-12-31 |