S & W Model Aso

FDA 510(k) K830873 · S & W Enterprises, Inc.

Substantially Equivalent

510(k) numberK830873

Submission

Device name
S & W Model Aso
Applicant
S & W Enterprises, Inc.
Mchenry, IL, US
Received
March 18, 1983
Decision date
May 13, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNC – Table, Obstetric (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4900
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code KNC

510(k)DeviceApplicantDecision
K001261L720 Examination ChairKNC · Traditional Luneau Gynecologie SA06/08/2000SE
K932035Non-Linting Delivery BlanketKNC · Traditional Amsco Sterile Recoveries, Inc.05/26/1994SE
K924420Medical Disposable BeddingKNC · Traditional Hill-Rom, Inc.12/10/1993SE
K914544BD6000 the Optima & BD5000 Birthing BedKNC · Traditional Lic Care, Inc.11/24/1993SE
K915779Affinity Bed Model 3600 SeriesKNC · Traditional Hill-Rom, Inc.02/24/1993SE
K903973Gardosi Birthing CushionKNC · Traditional Graphic Controls Corp.09/27/1990SE
K884868Obstetrical Safety SystemKNC · Traditional Buckman Co., Inc.03/01/1989SE
K870745Stryker Model 977 Birthing BedKNC · Traditional Stryker Corp.02/27/1987SE
K864194Palmer Obstetric BraceKNC · Traditional Ad-Tech Medical Instrument Corp01/14/1987SE
K862931Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional Global Medical Prods, Inc.08/07/1986SE

More from Global Medical Prods, Inc.

510(k)DeviceDecision
K864817S&W Model High-Low Mat Table, Various ModelsINQ · Traditional 01/05/1987SE
K841145Tilt Table 53INQ · Traditional 04/13/1984SE
K832768S & W SW52E W/Power Back LiftLGX · Traditional 09/20/1983SE
K830875S & W Model 29JFB · Traditional 04/08/1983SE
K830874S & W Model SW 37INQ · Traditional 04/08/1983SE

Questions and answers

When was S & W Model Aso cleared by the FDA?

S & W Model Aso (K830873) received a 510(k) decision of Substantially Equivalent on May 13, 1983, 56 days after the submission was received.

What is the product code of K830873?

The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.