Merivaara Obstetric Chair/Bed-Model 358

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K862931 ↗

FDA Product Code

KNC

Device Class

Class II

Regulation

21 CFR Part 884.4900

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Hospital Bed

  Class I

  FDA 510(k) K863748 Active Cleared 9 Oct 1986

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  Class II

  FDA 510(k) K961324 Active Cleared 2 Jul 1996

• Global Medical Cutting Biopsy Needle

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  FDA 510(k) K934256 Active Cleared 28 Mar 1994

• Merivaara Emergency Patient Trolley #436

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  FDA 510(k) K871556 Active Cleared 30 Apr 1987

• Merivaara Geriatric Chair Model 455

  Class I

  FDA 510(k) K862957 Active Cleared 21 Aug 1986

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  Class II

  FDA 510(k) K952275 Active Cleared 11 Oct 1995

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• What clinical settings is the Merivaara Obstetric Chair/Bed Model 358 primarily intended for use in?

  The Merivaara Obstetric Chair/Bed Model 358 is designed specifically for obstetrics and gynecology procedures, making it ideal for labor and delivery rooms where childbirth and related gynecological examinations are performed. Its design supports clinical procedures associated with these specialties.

• Is the Merivaara Obstetric Chair/Bed Model 358 a single-use or reusable device?

  The Merivaara Obstetric Chair/Bed Model 358 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. This makes it cost-effective for high-volume environments like labor and delivery rooms.

• How was the FDA clearance for this device determined, and what does that mean for its regulatory status?

  The Merivaara Obstetric Chair/Bed Model 358 received FDA clearance under the Traditional 510(k) pathway with a decision date of August 7, 1986. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, meaning the FDA determined it has the same intended use and technological characteristics as a previously cleared device. This classification does not imply ongoing approval but confirms compliance with FDA standards at the time of review.

• What are the key regulatory details for this device, including product code and associated registration numbers?

  The Merivaara Obstetric Chair/Bed Model 358 is classified under FDA product code KNC (Obstetric Table and Accessories) and falls under regulation number 884.4900. It is associated with multiple FDA registration numbers: 3040337865, 3007123908, 3033433849, 1824206, 3006697241, and 3007031002, reflecting its compliance with U.S. medical device regulations.