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510(k) K894667

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP by Pneumedics, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
July 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Pneumedics, Inc.

  • K904633 — SPIROLOOP, MODIFICATION (March 12, 1991)
  • K863087 — SPIROLOOP-PULMONARY EXERCISE SYSTEM (October 27, 1986)

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