The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Pain Management Optima, Model Pmo21-100-05, Pmo20-100-10cs, Pmo20-145-10cs.
| Device ID | K092337 |
| 510k Number | K092337 |
| Device Name: | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-10-16 |
| Summary: | summary |