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510(k) K853085

PAX METER by Peace Medical, Inc. — Product Code JAX

K853085 is an FDA 510(k) premarket notification submitted by Peace Medical, Inc. for the device "PAX METER". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Peace Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
July 23, 1985
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 Peace Medical, Inc.

  • K912352 — PEACE MODEL 100 CUFF MONITOR (August 2, 1991)
  • K902161 — DEMISTIFIER ISOLATION CHAMBER (October 15, 1990)

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)
  • 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)

FDA data resources