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510(k) K782148

HR UNIT by Parke-Davis Co. — Product Code IQP

K782148 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "HR UNIT". The FDA issued a decision of Substantially Equivalent on January 8, 1979. The device falls under product code IQP (Rotator, Transverse), a Class I device regulated under 21 CFR 890.3025. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1979
Date Received
December 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rotator, Transverse
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

Other clearances by Parke-Davis Co.

  • K861725 — INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT (December 4, 1986)
  • K862119 — DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR (August 29, 1986)
  • K855120 — ATI DISPOSABLE BIOLOGICAL TEST PACK (June 18, 1986)
  • K860570 — ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE (March 31, 1986)
  • K860290 — VIAPIC CENTRAL LINE CATHETER (March 18, 1986)
  • K852192 — DISPOSABLE STEAM BIOLOGICAL TEST PACK (November 1, 1985)
  • K841967 — DESERET THERMODILUTION CARDIAC OUTPUT (August 19, 1985)
  • K851327 — DESERET ARTERIAL CATHETER (June 14, 1985)
  • K852078 — SPECTRUM(TENTATIVE) (June 7, 1985)
  • K844840 — DESERET INTRODUCER SET (May 16, 1985)

FDA data resources