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510(k) K013812

SPIROLAB II, MODEL 29 by Sdi Diagnostics, Inc. — Product Code BZG

K013812 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "SPIROLAB II, MODEL 29". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Sdi Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
November 15, 2001
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 Sdi Diagnostics, Inc.

  • K150515 — IQSense Flow Sensor Mouthpiece (January 12, 2016)
  • K092813 — ASTRASONIC SPIROMETER, MODEL 29-8000 (July 16, 2010)
  • K061571 — ASTRA 300 (January 31, 2007)
  • K062913 — ASTRAGUARD PULMONARY FUNCTION FILTER (January 26, 2007)
  • K033939 — FLOSENSE II, MODEL 29-8040 (January 30, 2004)
  • K031643 — SPIROTEL, MODEL 29-1020 (December 9, 2003)
  • K011470 — SDI SB OFFICE, MODEL 29- (October 12, 2001)
  • K990962 — FLOSENSE, MODEL 29-8010 (January 7, 2000)
  • K934509 — PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER (October 21, 1993)

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)

FDA data resources