The following data is part of a premarket notification filed by M.c. Healthcare Products, Inc. with the FDA for Acclaim Series Qd6000,qd6001,qd6002 And Series Qd3000,qd3001, Qd3002.
| Device ID | K964515 |
| 510k Number | K964515 |
| Device Name: | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | M.C. HEALTHCARE PRODUCTS, INC. 4658 ONTARIO ST. Beamsville, Ontario, CA L0r 1b4 |
| Contact | Ralph N Thompson |
| Correspondent | Ralph N Thompson M.C. HEALTHCARE PRODUCTS, INC. 4658 ONTARIO ST. Beamsville, Ontario, CA L0r 1b4 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1996-12-31 |