The following data is part of a premarket notification filed by Home Care Instruments, Inc. with the FDA for Home Care Ear Examinatio Kit.
| Device ID | K944897 |
| 510k Number | K944897 |
| Device Name: | HOME CARE EAR EXAMINATIO KIT |
| Classification | Otoscope |
| Applicant | HOME CARE INSTRUMENTS, INC. 5251 DUKE ST. Alexandria, VA 22304 |
| Contact | Joseph Miller |
| Correspondent | Joseph Miller HOME CARE INSTRUMENTS, INC. 5251 DUKE ST. Alexandria, VA 22304 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-04 |
| Decision Date | 1994-11-08 |