FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS
K Number: K912378
·
Decision Mar 18, 1992
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
3
Review Days
294
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS
- K Number
- K912378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Davis Lead Aprons, Inc.
- Date Received
- May 29, 1991
- Decision Date
- March 18, 1992
- Product Code
- KPY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPY), ordered by most recent decision date.
DISPOSABLE THYROID COLLAR
FDA 510(k)
FDA Class 1
·Radiology
INTRA-ORAL THERMOPLASTIC SHIELD
FDA 510(k)
FDA Class 1
·Radiology
THERMOPLASTIC SHIELD
FDA 510(k)
FDA Class 1
·Radiology
UTK-DTE AUTILARY SHIELD
FDA 510(k)
FDA Class 1
·Radiology
AUKULYTE
FDA 510(k)
FDA Class 1
·Radiology
2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
FDA 510(k)
FDA Class 1
·Radiology