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510(k) K811623

SMR PARAGON CHAIR TABLE by Smr — Product Code LGX

K811623 is an FDA 510(k) premarket notification submitted by Smr for the device "SMR PARAGON CHAIR TABLE". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Smr has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
June 9, 1981
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 Smr

  • K801767 — DIMENSION I REFRACTION SYSTEM (September 16, 1980)

Other clearances for product code LGX

  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K894144 — POWER EXAMINATION TABLE MODEL # 405 (August 28, 1989)
  • K894134 — POWER EXAMINATION TABLE MODEL # 411 (August 28, 1989)
  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K882010 — POWER EXAMINATION TABLE (July 13, 1988)
  • K864072 — ADEC 1005-C CHAIR (November 7, 1986)
  • 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)

FDA data resources