The following data is part of a premarket notification filed by Stierlen-maquet Ag with the FDA for Mobile Operating Table 1132.01.
Device ID | K970807 |
510k Number | K970807 |
Device Name: | MOBILE OPERATING TABLE 1132.01 |
Classification | Table, Operating-room, Electrical |
Applicant | STIERLEN-MAQUET AG P.O. BOX 2162 Rastatt, DE 76411 |
Contact | Reinhard Pfeuffer |
Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1997-03-05 |
Decision Date | 1997-03-14 |
Summary: | summary |