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510(k) K102543

BRAVO PH MONITORING SYSTEM AND ACCESSORIES by Given Imaging , Ltd. — Product Code FFT

K102543 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "BRAVO PH MONITORING SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 1, 2010. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2010
Date Received
September 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type

Other clearances by Given Imaging , Ltd.

  • K180171 — PillCam Patency System (March 8, 2018)
  • K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (September 1, 2017)
  • K170839 — RAPID Web (May 26, 2017)
  • K151086 — ManoScan System (April 28, 2016)
  • K153466 — PillCam COLON 2 Capsule Endoscopy System (January 14, 2016)
  • K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM (December 17, 2014)
  • DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (January 29, 2014)
  • K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSC (August 12, 2013)
  • K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO (May 13, 2011)
  • K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (March 7, 2011)

Other clearances for product code FFT

  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002028 — BRAVO PH MONITORING SYSTEM (September 29, 2000)
  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K950087 — LOT 440 (February 6, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920849 — TRIP CIC CATHETER (March 17, 1995)
  • K934434 — CYBERRX MODEL 7200 (January 24, 1995)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)

FDA data resources