FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEM-SLEEVE B
K Number: K912257
·
Decision Dec 31, 1991
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
3
Review Days
223
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
- CHEM-SLEEVE B
- K Number
- K912257
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Haz-Med, Inc.
- Date Received
- May 22, 1991
- Decision Date
- December 31, 1991
- Product Code
- KME
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KME), ordered by most recent decision date.
READY-HEAT BLANKET
FDA 510(k)
FDA Class 1
·General Hospital
OREX MEDICAL BEDDING
FDA 510(k)
FDA Class 1
·General Hospital
DISPOSE-A-SHEET
FDA 510(k)
FDA Class 1
·General Hospital
DOCTOR DOWN --RESCUE WRAP
FDA 510(k)
FDA Class 1
·General Hospital
AMERICAN BURN SHEET
FDA 510(k)
FDA Class 1
·General Hospital
FOIL BABY BUNTING
FDA 510(k)
FDA Class 1
·General Hospital