The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Sondrex P.a.l. System.
| Device ID | K010388 |
| 510k Number | K010388 |
| Device Name: | SONDREX P.A.L. SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | OHMEDA MEDICAL 8880 GORMAN RD. Laurel, MD 20723 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F Profumo OHMEDA MEDICAL 8880 GORMAN RD. Laurel, MD 20723 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-08 |
| Decision Date | 2001-12-11 |