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 |