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510(k) K852439

FETA SCAN 1000 OBSTETRICAL IMAGER by International Biomedics, Inc. — Product Code HEM

K852439 is an FDA 510(k) premarket notification submitted by International Biomedics, Inc. for the device "FETA SCAN 1000 OBSTETRICAL IMAGER". The FDA issued a decision of Substantially Equivalent on August 30, 1985. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. International Biomedics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1985
Date Received
June 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by International Biomedics, Inc.

  • K031096 — MODIFICATION TO TRANSPORT INCUBATOR 185 (June 24, 2003)
  • K860933 — AIR-CUSHION TOCOTONOMETER (July 9, 1986)
  • K862072 — FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 (July 9, 1986)
  • K860295 — FETASCAN 1500 (May 19, 1986)

Other clearances for product code HEM

  • K951393 — ABACUS OB ULTRASOUNG COMPUTER SOFTWARE (May 1, 1995)
  • K942490 — BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND (February 15, 1995)
  • K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT (June 6, 1991)
  • K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (January 31, 1991)
  • K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER (August 10, 1990)
  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
  • K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE (June 12, 1989)
  • K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)

FDA data resources