The following data is part of a premarket notification filed by Pro-tech Services, Inc. with the FDA for Portable Sleep Data Recorder (psdr).
| Device ID | K033402 |
| 510k Number | K033402 |
| Device Name: | PORTABLE SLEEP DATA RECORDER (PSDR) |
| Classification | Ventilatory Effort Recorder |
| Applicant | PRO-TECH SERVICES, INC. 4338 HARBOUR POINTE BLVD. S.W. Mukilteo, WA 98275 |
| Contact | Neil Sheller |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2004-06-30 |