The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Skyboom Series.
| Device ID | K950192 |
| 510k Number | K950192 |
| Device Name: | SKYTRON SKYBOOM SERIES |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615 |
| Contact | David M Mehney |
| Correspondent | David M Mehney SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-04-03 |