FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K Number: K991160
·
Decision Sep 2, 1999
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
13
Applicant Total
6
Review Days
148
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
- ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
- K Number
- K991160
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stihler Electronic GmbH
- Date Received
- April 7, 1999
- Decision Date
- September 2, 1999
- Product Code
- BSB
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSB), ordered by most recent decision date.
THE BELMONT BUDDY LITE FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
THE BELMONT BUDDY LITE FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
BELMONT BUDDY PLUS FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
BELMONT BUDDY FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
MICROHEATER
FDA 510(k)
FDA Class 2
·Hematology
ASTOFLO
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Stihler Electronic GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K202197 | Astopad Patient Warming System | Sep 4, 2020 | Substantially Equivalent |
| K082758 | PRISMAFLO II | Dec 19, 2008 | Substantially Equivalent |
| K082765 | ASTOFLO PLUS | Dec 18, 2008 | Substantially Equivalent |
| K020103 | PRISMAFLO | Jul 24, 2002 | Substantially Equivalent |
| K991159 | PRISMATHERM II, ASTOLINE | Sep 3, 1999 | Substantially Equivalent |