Home / 510(k) Clearances / K812825

510(k) K812825

FLO-COR I by Biotrine Corp. — Product Code JAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1981
Date Received
October 8, 1981
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 Biotrine Corp.

  • K915060 — ASTECH HOME PEAK FLOW METER (September 11, 1992)
  • K883704 — MULTIICHALLENGE NEBULIZER SYSTEM (November 28, 1988)
  • K863134 — MULTISPIRO SA/100 (December 15, 1986)
  • K844226 — B-1000 (November 20, 1984)
  • K813414 — PEAK FLOW MONITOR (December 31, 1981)

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)
  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)