GENERAL PURPOSE TRANDUCER COVER

Transducer, Ultrasonic, Diagnostic

CIVCO MEDICAL INSTRUMENTS CO., INC.

The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for General Purpose Tranducer Cover.

Pre-market Notification Details

• Device ID: K970513
• 510k Number: K970513
• Device Name: GENERAL PURPOSE TRANDUCER COVER
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: CIVCO MEDICAL INSTRUMENTS CO., INC. 102 1ST ST. SOUTH Kalona, IA 52247
• Contact: J. William Jones
• Correspondent: J. William Jones; CIVCO MEDICAL INSTRUMENTS CO., INC. 102 1ST ST. SOUTH Kalona, IA 52247
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-11
• Decision Date: 1997-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841436104869	K970513	000
00841436101905	K970513	000
00841436103701	K970513	000
00841436103671	K970513	000
00841436103619	K970513	000
00841436103565	K970513	000
00841436103114	K970513	000
00841436103107	K970513	000
00841436103091	K970513	000
00841436103084	K970513	000
00841436102940	K970513	000
00841436103763	K970513	000
00841436103923	K970513	000
00841436103930	K970513	000
00841436104746	K970513	000
00841436104722	K970513	000
00841436101608	K970513	000
00841436104470	K970513	000
00841436104463	K970513	000
00841436104296	K970513	000
00841436104289	K970513	000
00841436104227	K970513	000
00841436104029	K970513	000
00841436103947	K970513	000
00841436102933	K970513	000
00841436102926	K970513	000
00841436102919	K970513	000
00841436114820	K970513	000
00841436114653	K970513	000
00841436114639	K970513	000
00841436114417	K970513	000
00841436114042	K970513	000
80841436118596	K970513	000
00841436121873	K970513	000
00841436121866	K970513	000
00841436121859	K970513	000
00841436122641	K970513	000
00841436112123	K970513	000
00841436101530	K970513	000
00841436101592	K970513	000
00841436102902	K970513	000
00841436102766	K970513	000
00841436102629	K970513	000
00841436102414	K970513	000
00841436102124	K970513	000
00841436102100	K970513	000
00841436102094	K970513	000
00841436101899	K970513	000
00841436101820	K970513	000
00841436101790	K970513	000
00841436121354	K970513	000
00841436106030	K970513	000
00841436110235	K970513	000
00841436120883	K970513	000
00841436120876	K970513	000
00841436120869	K970513	000
00841436114028	K970513	000
00841436111836	K970513	000
00841436111829	K970513	000
80841436104636	K970513	000
00841436118248	K970513	000
00841436110167	K970513	000
00841436108621	K970513	000
00841436120906	K970513	000
00841436120951	K970513	000
00841436101622	K970513	000
00841436109505	K970513	000
00841436118651	K970513	000
00841436104333	K970513	000
00841436103695	K970513	000
00841436103145	K970513	000
00841436103053	K970513	000
00841436101721	K970513	000
00841436101714	K970513	000
00841436101325	K970513	000
00841436102650	K970513	000
00841436101639	K970513	000
00841436101387	K970513	000
00841436101370	K970513	000
00841436110877	K970513	000
00841436110426	K970513	000
00841436110389	K970513	000
00841436110334	K970513	000
00841436110327	K970513	000
00841436110228	K970513	000
00841436110211	K970513	000
00841436110204	K970513	000
00841436110174	K970513	000
10841436108604	K970513	000
00841436111331	K970513	000
00841436111249	K970513	000
00841436111362	K970513	000
00841436101363	K970513	000
00841436101356	K970513	000
00841436101301	K970513	000
00841436101295	K970513	000
00841436101288	K970513	000
00841436101271	K970513	000
00841436101264	K970513	000
00841436101219	K970513	000
00841436100168	K970513	000
00841436119900	K970513	000
10841436108598	K970513	000