The following data is part of a premarket notification filed by Rest Mattress with the FDA for Rest Mattress.
Device ID | K971568 |
510k Number | K971568 |
Device Name: | REST MATTRESS |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | REST MATTRESS 19636 CLUB HOUSE RD. SUITE 120 Gaithersburg, MD 20879 |
Contact | Yoav Gershoni |
Correspondent | Yoav Gershoni REST MATTRESS 19636 CLUB HOUSE RD. SUITE 120 Gaithersburg, MD 20879 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-29 |
Decision Date | 1997-07-18 |