Citomat Autoclaves

FDA 510(k) K843234 · Lic-Orthion

Substantially Equivalent

510(k) numberK843234

Submission

Device name
Citomat Autoclaves
Applicant
Lic-Orthion
Washington, DC, US
Received
August 17, 1984
Decision date
October 25, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ECG – Sterilizer, Boiling Water
Device class
Class I (low risk)
Regulation
21 CFR 872.6710
Specialty
Dental

Other 510(k)s with product code ECG

510(k)DeviceApplicantDecision
K895164Eagle DSECG · Traditional American Sterilizer Co.11/17/1989SE
K811237Magnetic Retention UnitECG · Traditional Universiti Malaya06/16/1981SE
K810977Endodontic Post SystemsECG · Traditional Preat Corp.05/13/1981SE
K790290Ney Equi-HingeECG · Traditional Deringer-Ney, Inc.04/10/1979SE
K790078Bar & Rider, Screws, TubesECG · Traditional Eurodent, Inc.02/27/1979SE
K771266Steam SterilizerECG · Traditional Amsco Hospital Products Co.08/02/1977SE

More from Amsco Hospital Products Co.

510(k)DeviceDecision
K891649Patient Examination Gloves (Latex)LYY · Traditional 04/04/1989SE
K862022Lic-Orthion Multi-Therapy Treatment TableJFB · Traditional 06/19/1986SE
K854730Daisy (Absorbent Incontinence Shield)EYQ · Traditional 02/06/1986SE
K854729Adam (Absorbent Incontinence Shield)EYQ · Traditional 02/06/1986SE
K851471Tribag, Triband & Trifix-Reuseable Urine CollectorKNX · Traditional 06/12/1985SE
K851470Bibag, Biband & Bifix - Single Use Urine CollectorKNX · Traditional 06/12/1985SE
K843233Anatom SystemKLC · Traditional 10/25/1984SE
K830853Lavatory Seat HeightenerILS · Traditional 06/08/1983SE
K830855Sesam Treatment TableINQ · Traditional 04/05/1983SE
K830854Collapsable Lavatory Seat HeightenerILC · Traditional 04/05/1983SE

Questions and answers

When was Citomat Autoclaves cleared by the FDA?

Citomat Autoclaves (K843234) received a 510(k) decision of Substantially Equivalent on October 25, 1984, 69 days after the submission was received.

What is the product code of K843234?

The FDA product code is ECG – Sterilizer, Boiling Water, a Class I (low risk) device regulated under 21 CFR 872.6710.