Home / 510(k) Clearances / K904947

510(k) K904947

PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE by Planmeca USA, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
November 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Planmeca USA, Inc.

  • K111361 — PLANMED NUANCE EXCEL (September 23, 2011)
  • K081699 — PLANMECA SOVEREIGN (August 29, 2008)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K923533 — ADMARK (March 4, 1993)
  • K923461 — PM2002 PROLINE, PM2002 PROLINE EC (December 21, 1992)
  • K923462 — DELIGHT (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 1986)
  • K842359 — AUTOMATIC PATIENT CHAIR PM2000 & A (September 19, 1984)

Other clearances for product code BZG

  • K251777 — MESI mTABLET SPIRO (March 2, 2026)
  • K241843 — TD-7301 Spirometer (TD-7301) (November 20, 2024)
  • K231416 — Air Next (NVD-02) (January 18, 2024)
  • K230501 — Spirobank Oxi (December 15, 2023)
  • K230178 — EasyOne Sky Spirometer (October 19, 2023)
  • K222525 — Alveoair Digital Spirometer (August 28, 2023)
  • K222443 — Air Smart Extra Spirometer (August 9, 2023)
  • K213754 — SpiroHome Personal, SpiroHome Clinic (June 12, 2023)
  • K213872 — ComPAS2 (July 15, 2022)
  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)