The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isotechnologies Liftstation & Liftworks Software.
| Device ID | K912175 |
| 510k Number | K912175 |
| Device Name: | ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE |
| Classification | Stretcher, Wheeled, Powered |
| Applicant | ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Contact | Gilbert R Chenery |
| Correspondent | Gilbert R Chenery ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Product Code | INK |
| CFR Regulation Number | 890.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-06-07 |