The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Pressore Monitor.
| Device ID | K954670 |
| 510k Number | K954670 |
| Device Name: | PRESSORE MONITOR |
| Classification | Transducer, Miniature Pressure |
| Applicant | CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 439 Cleveland, OH 44106 |
| Contact | Robert N Schmidt |
| Correspondent | Robert N Schmidt CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE. SUITE 439 Cleveland, OH 44106 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1995-10-30 |