ASTOTHERM PLUS, ASTOTUBES, ASTOLINE


Device Classification Name

warmer, blood, non-electromagnetic radiation

510(k) Number K991160
Device Name ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
Applicant
STIHLER ELECTRONIC GMBH
30 northport rd.
sound beach, 
NY 
11789 -1734

Applicant Contact richard c lanzillotto
Correspondent
STIHLER ELECTRONIC GMBH
30 northport rd.
sound beach, 
NY 
11789 -1734

Correspodent Contact richard c lanzillotto
Regulation Number 864.9205
Classification Product Code
BSB  
Date Received 04/07/1999
Decision Date 09/02/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

General Hospital

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No