The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Lumex Air.
Device ID | K963674 |
510k Number | K963674 |
Device Name: | LUMEX AIR |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
Contact | Joseph Zanetti |
Correspondent | Joseph Zanetti LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-13 |
Decision Date | 1997-01-10 |
Summary: | summary |