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510(k) K770785

MONITOR, RESPIRATORY, TWO-GAS, RDC by Research Development Corp. — Product Code KLA

K770785 is an FDA 510(k) premarket notification submitted by Research Development Corp. for the device "MONITOR, RESPIRATORY, TWO-GAS, RDC". The FDA issued a decision of Substantially Equivalent on May 20, 1977. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Research Development Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1977
Date Received
May 2, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Research Development Corp.

  • K871870 — HSC UNIT ROD (July 21, 1987)
  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)
  • K771407 — LUNG VOLUME & PRESSURE MONITOR (August 4, 1977)
  • K771019 — LUNG-MECHANICS MONITOR (June 14, 1977)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)

Other clearances for product code KLA

  • K242666 — Fecobionics Anorectal System (February 12, 2025)
  • K242304 — RED (December 6, 2024)
  • K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (April 23, 2024)
  • K180135 — THD Anopress with THD SensyProbe (March 8, 2018)
  • K161785 — THD ANOPRESS (March 14, 2017)
  • K143031 — mcompass Biofeedback Anorectal Manometry System (July 7, 2015)
  • K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM (March 29, 2012)
  • K062362 — SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CA (April 13, 2007)
  • K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (January 16, 2004)
  • K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANOREC (October 9, 2003)

FDA data resources