PEAK FLOW MONITOR— 510(k) K813414

Substantially Equivalent

Biotrine Corp.

FDA 510(k) clearance K813414 for PEAK FLOW MONITOR, Substantially Equivalent on 1981-12-31. Applicant: Biotrine Corp.. Device class: 2.

Clearance details

Applicant: Biotrine Corp.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1981-12-07
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZH

K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B)2026-06-23
K252802 — Peak Flow Meter (PF-10(BR-PEF231))2026-05-29
K241338 — Peak Flow Meter2024-12-31
K232588 — Aluna 22024-11-25
K230423 — Electronic Peak Flow Meter2024-02-23

More clearances from Biotrine Corp.

K915060 — ASTECH HOME PEAK FLOW METER1992-09-11
K883704 — MULTIICHALLENGE NEBULIZER SYSTEM1988-11-28
K863134 — MULTISPIRO SA/1001986-12-15
K844226 — B-10001984-11-20
K812825 — FLO-COR I1981-10-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.