The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Mkm (multiple Coordinate Manipulator) System.
| Device ID | K942233 |
| 510k Number | K942233 |
| Device Name: | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM |
| Classification | Microscope, Surgical |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Cynthia A Gifford,rn |
| Correspondent | Cynthia A Gifford,rn CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | EPT |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-09 |
| Decision Date | 1994-07-01 |