The following data is part of a premarket notification filed by Pegasus Airwave, Inc. with the FDA for Pegasus Biwave Plus System.
Device ID | K944310 |
510k Number | K944310 |
Device Name: | PEGASUS BIWAVE PLUS SYSTEM |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
Contact | Thomas R Harrision |
Correspondent | Thomas R Harrision PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-02 |
Decision Date | 1995-03-17 |