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510(k) K945826

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS by Medical Device Inspection Co., Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1995
Date Received
November 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Medical Device Inspection Co., Inc.

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  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)
  • K912075 — C-SECTION TRAY (April 7, 1992)
  • K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY (February 24, 1992)
  • K920403 — XENON ARC ENDOSCOPE LIGHT SOURCE (February 21, 1992)

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