The following data is part of a premarket notification filed by National Health-care Equipment, Inc. with the FDA for Model #05 Aneroid Sphygmomanometer Kit.
| Device ID | K913814 |
| 510k Number | K913814 |
| Device Name: | MODEL #05 ANEROID SPHYGMOMANOMETER KIT |
| Classification | Mercury |
| Applicant | NATIONAL HEALTH-CARE EQUIPMENT, INC. 144 EAST KINGSBRIDGE RD. Mount Vernon, NY 11050 |
| Contact | Steven R Hersch |
| Correspondent | Steven R Hersch NATIONAL HEALTH-CARE EQUIPMENT, INC. 144 EAST KINGSBRIDGE RD. Mount Vernon, NY 11050 |
| Product Code | ELY |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1992-01-16 |