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510(k) K904633

SPIROLOOP, MODIFICATION by Pneumedics, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1991
Date Received
September 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

Other clearances by Pneumedics, Inc.

  • K894667 — MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP (October 19, 1989)
  • K863087 — SPIROLOOP-PULMONARY EXERCISE SYSTEM (October 27, 1986)

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