The following data is part of a premarket notification filed by Kalajian Ent. with the FDA for Soft Ear Stethoscope.
| Device ID | K870600 |
| 510k Number | K870600 |
| Device Name: | SOFT EAR STETHOSCOPE |
| Classification | Spreader, Cuff |
| Applicant | KALAJIAN ENT. 6601 TURKEY FARM RD. Chapel Hill, NC 27514 |
| Contact | Kalayjian, Md |
| Correspondent | Kalayjian, Md KALAJIAN ENT. 6601 TURKEY FARM RD. Chapel Hill, NC 27514 |
| Product Code | CBG |
| CFR Regulation Number | 868.5760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-10 |
| Decision Date | 1987-03-19 |