510(k) K913814
K913814 is an FDA 510(k) premarket notification submitted by National Health-Care Equipment, Inc. for the device "MODEL #05 ANEROID SPHYGMOMANOMETER KIT". The FDA issued a decision of Substantially Equivalent on January 16, 1992. The device falls under product code ELY (Mercury), a Class II device regulated under 21 CFR 872.3070. National Health-Care Equipment, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1992
- Date Received
- August 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercury
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type