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510(k) K921178

PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS by Medical Associated Services, Inc. — Product Code JAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1992
Date Received
March 9, 1992
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 Medical Associated Services, Inc.

  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K893845 — PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM (October 27, 1989)
  • K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS) (September 29, 1988)
  • K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (June 10, 1988)
  • K864087 — PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (November 7, 1986)

Other clearances for product code JAX

  • K990962 — FLOSENSE, MODEL 29-8010 (January 7, 2000)
  • 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)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)