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510(k) K810617

MOBILE MATIC AUTOMATIC DONOR SCALE by Lifeline Instruments, Inc. — Product Code KSQ

K810617 is an FDA 510(k) premarket notification submitted by Lifeline Instruments, Inc. for the device "MOBILE MATIC AUTOMATIC DONOR SCALE". The FDA issued a decision of Substantially Equivalent on April 7, 1981. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Lifeline Instruments, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1981
Date Received
March 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Blood Mixing And Blood Weighing
Device Class
Class I
Regulation Number
864.9195
Review Panel
HE
Submission Type

Other clearances by Lifeline Instruments, Inc.

  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)

Other clearances for product code KSQ

  • K842746 — HYCEL ROTOR-MIXER AND/OR MULTI (August 17, 1984)
  • K820712 — SEPCOR UNIT COLLECTION MONITOR (May 7, 1982)
  • K812533 — PLATELET AGITATOR (September 29, 1981)
  • K802608 — HEMATIC BLOOD MIXER (December 11, 1980)
  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K780189 — PLATELET ROTATOR (March 30, 1978)
  • K760743 — DONORMATIC (BLOOD COLLECTION DEVICE) (December 6, 1976)

FDA data resources