FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELBOW PROTECTOR
K Number: K780171
·
Decision Feb 6, 1978
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
4
Review Days
4
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
- ELBOW PROTECTOR
- K Number
- K780171
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Stat Medical Corp.
- Date Received
- February 2, 1978
- Decision Date
- February 6, 1978
- Product Code
- FMP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMP), ordered by most recent decision date.
Invictus Medical GelShield
FDA 510(k)
FDA Class 1
·General Hospital
COMFEEL PLUS PRESSURE RELIEF DRESSING
FDA 510(k)
FDA Class 1
·General Hospital
MEDSURG STERILE IMAGING PRODUCTS
FDA 510(k)
FDA Class 1
·General Hospital
DECUBICARE PADS & ACCESSORIES
FDA 510(k)
FDA Class 1
·General Hospital
HEEL OR ELBOW PROTECTOR
FDA 510(k)
FDA Class 1
·General Hospital
SPENCO DERMAL PADS
FDA 510(k)
FDA Class 1
·General Hospital