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510(k) K893845

PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM by Medical Associated Services, Inc. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
May 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Medical Associated Services, Inc.

  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS) (September 29, 1988)
  • K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (June 10, 1988)
  • K864087 — PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (November 7, 1986)

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  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)