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510(k) K951718

HM-SPIRO by Hill-Med, Inc. — Product Code BZG

K951718 is an FDA 510(k) premarket notification submitted by Hill-Med, Inc. for the device "HM-SPIRO". The FDA issued a decision of Substantially Equivalent on December 20, 1995. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Hill-Med, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1995
Date Received
April 13, 1995
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 Hill-Med, Inc.

  • K993991 — HM-930 ELECTROSURGICAL UNIT (May 30, 2000)
  • K981781 — ELECTROSURGICAL UNIT (December 4, 1998)
  • K961473 — HM-88011 SOLID STATE ELECTR SURGICAL UNIT (May 7, 1996)
  • K940140 — HM-CRYO (June 27, 1994)
  • K932896 — HM-0690 COLPOSCOPE (March 23, 1994)
  • K932782 — HM-0660 (March 23, 1994)
  • K932817 — HM-880 I (March 9, 1994)
  • K932818 — HM-880 (February 25, 1994)
  • K932720 — HM-0970 (September 7, 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