Sonocare

FDA 510(k) K844034 · Echo Ultrasound

Substantially Equivalent

510(k) numberK844034

Submission

Device name
Sonocare
Applicant
Echo Ultrasound
Lewistown, PA, US
Received
October 16, 1984
Decision date
January 23, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DYO – Band, Material, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Specialty
Dental

Other 510(k)s with product code DYO

510(k)DeviceApplicantDecision
K935152Dentaurum Dentaform Bands, Dentaurum StandardDYO · Traditional Dentauraum, Inc.01/31/1994SE
K931980Stainless Steel Orthodontic ProductsDYO · Traditional Ortho Organizers, Inc.09/01/1993SE

More from Ortho Organizers, Inc.

510(k)DeviceDecision
K924054PhonocardiographDQC · Traditional 01/22/1993SE
K903414Transesophageal Probe Holder & Disinfecting ColumnDXK · Traditional 09/19/1990SE
K893225Couplant Warming DeviceIYO · Traditional 10/12/1989SE
K872519Sterilized Omni GelJOT · Traditional 08/03/1987SE
K844120Ultrasonic Scanner Calibration & Test ObjectsGXX · Traditional 01/23/1985SE

Questions and answers

When was Sonocare cleared by the FDA?

Sonocare (K844034) received a 510(k) decision of Substantially Equivalent on January 23, 1985, 99 days after the submission was received.

What is the product code of K844034?

The FDA product code is DYO – Band, Material, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.