FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A

K Number: K901725 · Decision Aug 15, 1990
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
6
Review Days
121

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Basic Information

Device Name
ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
K Number
K901725
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1570
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Kretztechnik AG
Date Received
April 16, 1990
Decision Date
August 15, 1990
Product Code
ITX
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
ITX Transducer, Ultrasonic, Diagnostic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.

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Other Clearances by Kretztechnik AG

K Number Device Name
K925354 COMBISON(R) 311
K904070 COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A
K910966 SECTOR TRANSDUCER MODEL NO. AWP3.5/A
K904665 MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
K901655 1 TRANSDUCER FOR COMBISON 310A