GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE

Transducer, Ultrasonic, Diagnostic

PROTEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Ge Medical-needle Guide For Sv, Tr Andatf, Acuson-needle Guide.

Pre-market Notification Details

• Device ID: K971115
• 510k Number: K971115
• Device Name: GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Contact: Rick L Pruter
• Correspondent: Rick L Pruter; PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-27
• Decision Date: 1997-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841912102730	K971115	000
00841912102600	K971115	000
00841912102594	K971115	000
00841912102587	K971115	000
00841912102570	K971115	000
00841912102563	K971115	000
00841912102549	K971115	000
00841912102532	K971115	000
00841912102525	K971115	000
00841912102617	K971115	000
00841912102624	K971115	000
00841912102648	K971115	000
00841912102723	K971115	000
00841912102716	K971115	000
00841912102709	K971115	000
00841912102693	K971115	000
00841912102686	K971115	000
00841912102679	K971115	000
00841912102662	K971115	000
00841912102655	K971115	000
00841912102501	K971115	000
00841912102495	K971115	000
10841912106384	K971115	000
10841912106308	K971115	000
00841912106707	K971115	000
00841912106622	K971115	000
10841912106612	K971115	000
10841912106605	K971115	000
10841912106759	K971115	000
00841912106202	K971115	000
10841912106124	K971115	000
10841912106025	K971115	000
00841912105830	K971115	000
00841912102488	K971115	000
00841912102471	K971115	000
00841912102464	K971115	000
00841912102440	K971115	000
00841912102433	K971115	000
00841912102426	K971115	000
00841912102419	K971115	000
00841912105922	K971115	000
10841912107107	K971115	000
00841912102747	K971115	000
10841912105912	K971115	000
10841912105127	K971115	000
10841912105080	K971115	000
10841912104878	K971115	000
00841912104659	K971115	000
00841912104208	K971115	000
00841912104116	K971115	000
00841912104109	K971115	000
00841912103140	K971115	000
10841912105189	K971115	000
10841912105288	K971115	000
10841912105462	K971115	000
10841912105905	K971115	000
10841912105899	K971115	000
10841912105776	K971115	000
10841912105769	K971115	000
10841912105752	K971115	000
10841912105745	K971115	000
10841912105738	K971115	000
10841912105721	K971115	000
00841912103126	K971115	000
00841912102631	K971115	000
10841912104939	K971115	000
10841912104922	K971115	000
10841912104915	K971115	000
10841912104908	K971115	000
10841912104892	K971115	000
10841912104885	K971115	000
00841912104864	K971115	000
00841912104420	K971115	000
00841912105229	K971115	000
00841912105250	K971115	000
10841912105455	K971115	000
00841912102556	K971115	000
00841912102518	K971115	000
20841912104059	K971115	000
00841912105786	K971115	000
10841912106018	K971115	000
10841912105943	K971115	000
10841912105875	K971115	000
00841912105793	K971115	000
00841912103133	K971115	000