Merivaara Obstetric Chair/Bed Model 358

FDA 510(k) K852174 · Daun International, Inc.

Substantially Equivalent

510(k) numberK852174

Submission

Device name
Merivaara Obstetric Chair/Bed Model 358
Applicant
Daun International, Inc.
Chicago, IL, US
Received
May 20, 1985
Decision date
September 6, 1985
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

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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
K851553Meriuaara & Eracare WheelchairsIOR · Traditional 07/09/1985SE
K851550Merivaara Geriatric ChairINM · Traditional 07/09/1985SE
K851548Ahlbergs Kombi I & Kombi II Mobile Transfer ChairsINM · Traditional 07/09/1985SE
K852173Merivaara Crib Trolley-Model 381FMS · Traditional 06/17/1985SE
K851552Merivaara Hospital BedFNJ · Traditional 05/08/1985SE
K851551Merivaara Electric Hospital Bed & AccessoriesFNL · Traditional 05/08/1985SE

Questions and answers

When was Merivaara Obstetric Chair/Bed Model 358 cleared by the FDA?

Merivaara Obstetric Chair/Bed Model 358 (K852174) received a 510(k) decision of Substantially Equivalent on September 6, 1985, 109 days after the submission was received.

What is the product code of K852174?

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