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510(k) K782064

TABLE, EXAMINING-TWO EIGHTY by Amsco Co. — Product Code ETF

K782064 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "TABLE, EXAMINING-TWO EIGHTY". The FDA issued a decision of Substantially Equivalent on December 28, 1978. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1978
Date Received
December 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type

Other clearances by Amsco Co.

  • K912471 — EAGLE 3000 SDS (June 26, 1992)
  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)

Other clearances for product code ETF

  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910781 — #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (May 15, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)

FDA data resources