The following data is part of a premarket notification filed by Microwave Medical Systems, Inc. with the FDA for Pdm-1 Device:capd Disinfecting Device, Modified.
| Device ID | K913110 |
| 510k Number | K913110 |
| Device Name: | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Contact | Richard S Grabowy |
| Correspondent | Richard S Grabowy MICROWAVE MEDICAL SYSTEMS, INC. 9 GOLDSMITH ST. P.O. BOX 188 Littleton, MA 01460 -0188 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1991-10-10 |