The following data is part of a premarket notification filed by Mannesmann Demag Corp. with the FDA for Pk-ac Powered Patient Manupulating Device.
| Device ID | K854058 |
| 510k Number | K854058 |
| Device Name: | PK-AC POWERED PATIENT MANUPULATING DEVICE |
| Classification | Lift, Patient, Ac-powered |
| Applicant | MANNESMANN DEMAG CORP. 29201 AURORA RD. P.O. BOX 39245 Solon, OH 44139 |
| Contact | David R Marshall |
| Correspondent | David R Marshall MANNESMANN DEMAG CORP. 29201 AURORA RD. P.O. BOX 39245 Solon, OH 44139 |
| Product Code | FNG |
| CFR Regulation Number | 880.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-03 |
| Decision Date | 1986-02-25 |