The following data is part of a premarket notification filed by Dynamedics Corporation with the FDA for Dynamedics Asar.
| Device ID | K941083 |
| 510k Number | K941083 |
| Device Name: | DYNAMEDICS ASAR |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | DYNAMEDICS CORPORATION 30 ADELAIDE ST. NORTH, #205 London, Ontario, CA N6b 3n5 |
| Contact | Stephen Matheson |
| Correspondent | Stephen Matheson DYNAMEDICS CORPORATION 30 ADELAIDE ST. NORTH, #205 London, Ontario, CA N6b 3n5 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-08 |
| Decision Date | 1995-01-20 |