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510(k) K791399

ACU-ALERT by Acumed Instruments Corp.

K791399 is an FDA 510(k) premarket notification submitted by Acumed Instruments Corp. for the device "ACU-ALERT". The FDA issued a decision of Substantially Equivalent on October 11, 1979. Acumed Instruments Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1979
Date Received
July 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Acumed Instruments Corp.

  • K863627 — MICRO SURGICAL DRILL SYSTEM (October 2, 1986)
  • K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL (September 24, 1985)
  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853658 — BURS FOR MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL. (December 5, 1979)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

FDA data resources