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510(k) K880756

MODEL PM-20A PHYSIOLOGICAL MONITOR by Advanced Medical Systems, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1988
Date Received
February 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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  • K940898 — MODEL IM77 INTRAPARTUM FETAL MONITOR (March 1, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (January 9, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)

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