MODEL #05 ANEROID SPHYGMOMANOMETER KIT
FDA 510(k) clearance K913814 · decided 1992-01-16
Clearance details
- K-number
- K913814
- Device name
- MODEL #05 ANEROID SPHYGMOMANOMETER KIT
- Applicant
- National Health-Care Equipment, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-26
- Decision date
- 1992-01-16
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- ELY
- Device class
- 2
- Regulation number
- 872.3070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mount Vernon, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch National Health-Care Equipment
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DENTAL MERCURY (K093587) | Dmg USA, Inc. | 2010-01-21 |
| MERCURY DENTAL (K973548) | Aleaciones Dentales Zeyco, S.A. DE C.V. | 1998-03-23 |
| DENTAL-QUECKSILBER (DENTAL MERCURY) (K902388) | Degussa AG | 1990-06-28 |
Recalls involving this device
No recalls on record reference this clearance.