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510(k) K812825

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

K812825 is an FDA 510(k) premarket notification submitted by Biotrine Corp. for the device "FLO-COR I". The FDA issued a decision of Substantially Equivalent on October 26, 1981. The device falls under product code JAX (Pneumotachometer), a Class II device regulated under 21 CFR 868.2550. Biotrine Corp. has at least 5 other 510(k) clearances on record.

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)

FDA data resources