CLEAN PEAK FLOW METER— 510(k) K091412

Substantially Equivalent

Viasys Healthcare GmbH

FDA 510(k) clearance K091412 for CLEAN PEAK FLOW METER, Substantially Equivalent on 2009-08-21. Applicant: Viasys Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Viasys Healthcare GmbH
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2009-05-13
Decision date: 2009-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoechberg, DE

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 Viasys Healthcare GmbH

K092324 — SPIROPRO2009-09-03
K091505 — COR12+2009-06-10
K081823 — MASTERSCREEN PAED - BABY BODY2009-05-18
K080510 — VIP PULMONARY FUNCTION SYSTEM2008-08-20
K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT2008-06-26

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