FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ID BRACLETS, ADULT & INFANT
K Number: K771158
·
Decision Oct 13, 1977
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
59
Applicant Total
1
Review Days
108
Basic Information
- Device Name
- ID BRACLETS, ADULT & INFANT
- K Number
- K771158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- DIVERS-A-MED
- Date Received
- June 27, 1977
- Decision Date
- October 13, 1977
- Product Code
- LDR
- 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 |
|---|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDR), ordered by most recent decision date.
DEKA Infusion System, DEKA Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
DEKA Infusion System, DEKA Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Volumetric Infusion Controller
FDA 510(k)
FDA Class 2
·General Hospital
PACER MODEL 100 INFUSION CONTROLLER
FDA 510(k)
FDA Class 2
·General Hospital
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
FDA 510(k)
FDA Class 2
·General Hospital
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
FDA 510(k)
FDA Class 2
·General Hospital