Home / 510(k) Clearances / K912234

510(k) K912234

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION by Somnitec, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1991
Date Received
May 17, 1991
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 Somnitec, Inc.

  • K911989 — GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. (July 30, 1991)
  • K912817 — SOMNIMIC (R) (July 26, 1991)
  • K911990 — ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. (June 21, 1991)

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)