The following data is part of a premarket notification filed by Equi-tron Mfg., Inc. with the FDA for 2000 Modular Thirty-nine.
| Device ID | K962763 |
| 510k Number | K962763 |
| Device Name: | 2000 MODULAR THIRTY-NINE |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | EQUI-TRON MFG., INC. 820 NIPISSING RD., UNITS 3 & 4 Milton, Ontario, CA L9t 4z9 |
| Contact | James H Alexander |
| Correspondent | James H Alexander EQUI-TRON MFG., INC. 820 NIPISSING RD., UNITS 3 & 4 Milton, Ontario, CA L9t 4z9 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-10-07 |