The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Silent Partner Model 10-1001.
| Device ID | K861012 |
| 510k Number | K861012 |
| Device Name: | SILENT PARTNER MODEL 10-1001 |
| Classification | Generator, Oxygen, Portable |
| Applicant | MEDICAL DEVICES, INC. 5000 DUFFERIN STREET, UNIT N DOWNSVIEW Ontario M3h 5t5, CA |
| Contact | Steven Serber |
| Correspondent | Steven Serber MEDICAL DEVICES, INC. 5000 DUFFERIN STREET, UNIT N DOWNSVIEW Ontario M3h 5t5, CA |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-04-04 |