The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for 3 Channel Knee Electronic Amplified Stethoscope.
| Device ID | K991756 |
| 510k Number | K991756 |
| Device Name: | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIO-RESEARCH ASSOCIATES, INC. 4113 NORTH PORT WASHINGTON RD. Milwaukee, WI 53212 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-24 |
| Decision Date | 1999-12-10 |
| Summary: | summary |