The following data is part of a premarket notification filed by Steth-shield, Inc. with the FDA for Steth-shield Accessory To A Stethoscope.
| Device ID | K882324 |
| 510k Number | K882324 |
| Device Name: | STETH-SHIELD ACCESSORY TO A STETHOSCOPE |
| Classification | Stethoscope, Manual |
| Applicant | STETH-SHIELD, INC. 1360 GOODYEAR BLVD. Akron, OH 44305 |
| Contact | Kenneth R Turner |
| Correspondent | Kenneth R Turner STETH-SHIELD, INC. 1360 GOODYEAR BLVD. Akron, OH 44305 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-06 |
| Decision Date | 1988-07-18 |