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510(k) K864072

ADEC 1005-C CHAIR by Cherne Industries, Inc. — Product Code LGX

K864072 is an FDA 510(k) premarket notification submitted by Cherne Industries, Inc. for the device "ADEC 1005-C CHAIR". The FDA issued a decision of Substantially Equivalent on November 7, 1986. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Cherne Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
October 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Examination, Medical, Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
HO
Submission Type

Other clearances by Cherne Industries, Inc.

  • K860015 — MODIFIED CHERNE CAD DETECTOR (April 23, 1986)
  • K852900 — CVERNE CAD DETECTOR (September 25, 1985)

Other clearances for product code LGX

  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K894134 — POWER EXAMINATION TABLE MODEL # 411 (August 28, 1989)
  • K894144 — POWER EXAMINATION TABLE MODEL # 405 (August 28, 1989)
  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K882010 — POWER EXAMINATION TABLE (July 13, 1988)
  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K845023 — STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (January 28, 1985)
  • K830294 — MEDICAL EXAM TABLE (January 11, 1984)
  • K832768 — S & W SW52E W/POWER BACK LIFT (September 20, 1983)
  • K820823 — MULTIPLE, MODEL #17 (April 21, 1982)

FDA data resources