PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE— 510(k) K904947

Name: FDA 510(k) clearance K904947
Creator: U.S. Food and Drug Administration
Published: 1991-01-30

Substantially Equivalent

Planmeca USA, Inc.

FDA 510(k) clearance K904947 for PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE, Substantially Equivalent on 1991-01-30. Applicant: Planmeca USA, Inc.. Device class: 2.

Clearance details

Applicant: Planmeca USA, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1990-11-01
Decision date: 1991-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

view all

K251777 — MESI mTABLET SPIRO2026-03-02
K241843 — TD-7301 Spirometer (TD-7301)2024-11-20
K231416 — Air Next (NVD-02)2024-01-18
K230501 — Spirobank Oxi2023-12-15
K230178 — EasyOne Sky Spirometer2023-10-19

More clearances from Planmeca USA, Inc.

view all

K111361 — PLANMED NUANCE EXCEL2011-09-23
K081699 — PLANMECA SOVEREIGN2008-08-29
K923534 — PM2002 PROLINE1994-01-31
K923533 — ADMARK1993-03-04
K923461 — PM2002 PROLINE, PM2002 PROLINE EC1992-12-21

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