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510(k) K872086

ACUSYST-JR by Endotronics, Inc. — Product Code KJH

K872086 is an FDA 510(k) premarket notification submitted by Endotronics, Inc. for the device "ACUSYST-JR". The FDA issued a decision of Substantially Equivalent on June 15, 1987. The device falls under product code KJH (Apparatus, Perfusion), a Class I device regulated under 21 CFR 864.2240. Endotronics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1987
Date Received
June 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Perfusion
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances by Endotronics, Inc.

  • K875151 — ACUSYST-P/3X (January 12, 1988)
  • K864334 — ACUSYST-P (CELL CULTURE EQUIPMENT) (November 24, 1986)

Other clearances for product code KJH

  • K875151 — ACUSYST-P/3X (January 12, 1988)
  • K864334 — ACUSYST-P (CELL CULTURE EQUIPMENT) (November 24, 1986)

FDA data resources