SONOCARE— 510(k) K844034

Substantially Equivalent

Echo Ultrasound

FDA 510(k) clearance K844034 for SONOCARE, Substantially Equivalent on 1985-01-23. Applicant: Echo Ultrasound. Device class: 1.

Clearance details

Applicant: Echo Ultrasound
Product code: Code DYO
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1984-10-16
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewistown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYO

K935152 — DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD1994-01-31
K931980 — STAINLESS STEEL ORTHODONTIC PRODUCTS1993-09-01

More clearances from Echo Ultrasound

K924054 — PHONOCARDIOGRAPH1993-01-22
K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN1990-09-19
K893225 — COUPLANT WARMING DEVICE1989-10-12
K872519 — STERILIZED OMNI GEL1987-08-03
K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS1985-01-23

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