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510(k) K894627

BT-338N ELECTRONIC CLINICAL THERMOMETER by Integrated Display Technology, Ltd. — Product Code FCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1989
Date Received
July 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Integrated Display Technology, Ltd.

  • K951977 — DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 (October 24, 1995)
  • K941490 — BLOOD PRESSURE METER MODEL NO. BPM888 (November 29, 1994)
  • K942336 — AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (November 28, 1994)
  • K853130 — INTEGRATED DISPLAY TECHNOLOGY LTD. (November 8, 1985)

Other clearances for product code FCI

  • K895885 — AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING (February 9, 1990)
  • K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE (March 2, 1988)
  • K853104 — DISPOSABLE, STERILE BIOPSY PUNCH (October 4, 1985)
  • K831317 — BIOPSY ATTACHMENT (May 18, 1983)