DAVOL EMS ADAPTER, CAT. NO. 13-7664
FDA 510(k) clearance K800317 · decided 1980-03-12
Clearance details
- K-number
- K800317
- Device name
- DAVOL EMS ADAPTER, CAT. NO. 13-7664
- Applicant
- Electrocaine Medical System
- Decision
- Substantially Equivalent
- Date received
- 1980-02-12
- Decision date
- 1980-03-12
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Electrocaine Medical System
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.
Recalls involving this device
No recalls on record reference this clearance.