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510(k) K891672

PUL-TRON 100K PROFESSIONAL SPIROMETER by Advanced Medical Systems, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
March 21, 1989
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

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  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
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  • K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (January 9, 1990)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

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