FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTEMP
K Number: K896018
·
Decision Feb 9, 1990
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
3
Review Days
116
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
- BIOTEMP
- K Number
- K896018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medadvances, Inc.
- Date Received
- October 16, 1989
- Decision Date
- February 9, 1990
- Product Code
- LGZ
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGZ), ordered by most recent decision date.
°M Warmer System with °M Station
FDA 510(k)
FDA Class 2
·General Hospital
Fluido Compact System
FDA 510(k)
FDA Class 2
·General Hospital
Fluido® AirGuard System
FDA 510(k)
FDA Class 2
·General Hospital
°M Warmer System
FDA 510(k)
FDA Class 2
·General Hospital
Fluido Compact Blood and Fluid Warming System
FDA 510(k)
FDA Class 2
·General Hospital
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
FDA 510(k)
FDA Class 2
·General Hospital