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510(k) K974697

REUSABLE FINGER SENSOR 3444 by Bci Intl., Inc. — Product Code DQH

K974697 is an FDA 510(k) premarket notification submitted by Bci Intl., Inc. for the device "REUSABLE FINGER SENSOR 3444". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code DQH (Cardiograph, Apex (Vibrocardiograph)), a Class II device regulated under 21 CFR 870.2310. Bci Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
December 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cardiograph, Apex (Vibrocardiograph)
Device Class
Class II
Regulation Number
870.2310
Review Panel
CV
Submission Type

Other clearances by Bci Intl., Inc.

  • K991086 — CAPNOCHECK II, MODEL 8400 (June 9, 1999)
  • K991410 — 3402 HANDHELD PULSE OXIMETER (June 9, 1999)
  • K984618 — BCI MINI-TORR PLUS, MODEL 6004 (March 25, 1999)
  • K983796 — 6004 NIBP MONITOR WITH TEMPERATURE (January 22, 1999)
  • K982279 — VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 (September 25, 1998)
  • K981939 — AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (August 20, 1998)
  • K980714 — BCI 3401 HANDHELD PULSE OXIMETER (March 25, 1998)
  • K970801 — BCI MODEL 6004 NIBP MONITOR (6004) (November 12, 1997)
  • K970209 — CAPNOCHECK PLUS (April 18, 1997)
  • K963496 — OXI TEMP (November 26, 1996)

FDA data resources