510(k) K913814
- Device
- MODEL #05 ANEROID SPHYGMOMANOMETER KIT
- Applicant
- NATIONAL HEALTH-CARE EQUIPMENT, INC.
- 510(k) number
- K913814
- Product code
- ELY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-16
- Date received
- 1991-08-26
- Regulation
- 872.3070
- Classification name
- Mercury
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN R HERSCH
- Address
- 144 E. Kingsbridge Rd. Mount Vernon NY US 11050 11050
FDA Registration Numbers#
- 3003794907
- 3038718579
- 3012421607
- 2648744
- 3012187973
- 3008912871
- 2024312
- 3004140838
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ELY #
Legacy Summary#
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FDA Review#
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