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510(k) K840934

MEDILOG PH1 by Oxford Medilog, Inc. — Product Code EXW

K840934 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "MEDILOG PH1". The FDA issued a decision of Substantially Equivalent on June 28, 1984. The device falls under product code EXW (Pill, Radio), a Class II device regulated under 21 CFR 876.1725. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1984
Date Received
March 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pill, Radio
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Oxford Medilog, Inc.

  • K923737 — MODEL MEDILOG RAPIDE (January 5, 1994)
  • K920295 — MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (August 18, 1992)
  • K912890 — MODEL SONICAID AXIS (January 9, 1992)
  • K912639 — SONICAID TEAM (December 31, 1991)
  • K904763 — MENTOR EEG SYSTEM (April 10, 1991)
  • K902690 — SONICAID MODEL MERIDIAN 800 (February 5, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K896535 — MEDILOG OPTIMA (January 18, 1990)
  • K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
  • K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)

FDA data resources