The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Dinamap Models 1160 And 1165.
| Device ID | K782073 |
| 510k Number | K782073 |
| Device Name: | DINAMAP MODELS 1160 AND 1165 |
| Classification | Computer, Blood-pressure |
| Applicant | APPLIED MEDICAL RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-13 |
| Decision Date | 1979-02-23 |