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510(k) K910452

RESPI-PAK RT-PAK by Cns, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1991
Date Received
February 1, 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 Cns, Inc.

  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
  • K953772 — BREATHE RIGHT NASAL STRIP (October 20, 1995)
  • K950273 — SLEEP TEST(TM) (September 19, 1995)
  • K921220 — BREATHE RIGHT (October 7, 1993)
  • K912436 — AM-PAK (October 18, 1991)
  • K904432 — SLEEP I/T-5 AND SLEEP I/T-8 (July 10, 1991)
  • K901549 — CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. (October 24, 1990)
  • K897107 — POLY G PHYSIOLOGICAL DATA RECORDER (March 12, 1990)
  • K860829 — CNS 4/8 AND CT 48.1 SOFTWARE (May 29, 1986)

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