The following data is part of a premarket notification filed by Metek Gmbh with the FDA for Massage Mattress Vm9100rm.
Device ID | K070672 |
510k Number | K070672 |
Device Name: | MASSAGE MATTRESS VM9100RM |
Classification | Table, Physical Therapy, Multi Function |
Applicant | METEK GMBH STAMMWEG 8 Leinefelde, DE 37327 |
Contact | Stefan Ziegenfub |
Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-03-12 |
Decision Date | 2007-06-26 |
Summary: | summary |