SONICAID MODEL P110 FETAL HEAR DETECTOR— 510(k) K933816

Name: FDA 510(k) clearance K933816
Creator: U.S. Food and Drug Administration
Published: 1994-12-22

Substantially Equivalent

Oxford Instruments, Plc.

FDA 510(k) clearance K933816 for SONICAID MODEL P110 FETAL HEAR DETECTOR, Substantially Equivalent on 1994-12-22. Applicant: Oxford Instruments, Plc.. Device class: 2.

Clearance details

Applicant: Oxford Instruments, Plc.
Product code: Code HEL
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1993-08-04
Decision date: 1994-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEL

view all

K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P2001-07-09
K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING2001-06-22
K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER1998-12-11
K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M0061997-06-06
K930714 — SONICAID MODEL TEAM FECG IUP1995-08-24

More clearances from Oxford Instruments, Plc.

view all

K981405 — SYNERGY LT1998-07-16
K961636 — MEDILOG VISION1997-01-17
K961642 — MEDILOG MR951997-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.