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510(k) K770061

VO RESPIRATORY PNEUMOTACHOGRAPH by Research Development Corp. — Product Code JAX

K770061 is an FDA 510(k) premarket notification submitted by Research Development Corp. for the device "VO RESPIRATORY PNEUMOTACHOGRAPH". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Research Development Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1977
Date Received
January 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumotachometer
Device Class
Class II
Regulation Number
868.2550
Review Panel
AN
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)
  • K770785 — MONITOR, RESPIRATORY, TWO-GAS, RDC (May 20, 1977)

Other clearances for product code JAX

  • K990962 — FLOSENSE, MODEL 29-8010 (January 7, 2000)
  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K853085 — PAX METER (September 3, 1985)
  • K833265 — RESPIRATORY FLOW MODULE (November 28, 1983)
  • K812825 — FLO-COR I (October 26, 1981)
  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)

FDA data resources