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510(k) K831998

BIRTHWELL BIRTHING SYSTEM by Qulab Co. — Product Code KNC

K831998 is an FDA 510(k) premarket notification submitted by Qulab Co. for the device "BIRTHWELL BIRTHING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
June 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetric (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type

Other clearances for product code KNC

  • K001261 — L720 EXAMINATION CHAIR (June 8, 2000)
  • K932035 — NON-LINTING DELIVERY BLANKET (May 26, 1994)
  • K924420 — MEDICAL DISPOSABLE BEDDING (December 10, 1993)
  • K914544 — BD6000 THE OPTIMA & BD5000 BIRTHING BED (November 24, 1993)
  • K915779 — AFFINITY BED MODEL 3600 SERIES (February 24, 1993)
  • K903973 — GARDOSI BIRTHING CUSHION (September 27, 1990)
  • K884868 — OBSTETRICAL SAFETY SYSTEM (March 1, 1989)
  • K870745 — STRYKER MODEL 977 BIRTHING BED (February 27, 1987)
  • K864194 — PALMER OBSTETRIC BRACE (January 14, 1987)
  • K862931 — MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (August 7, 1986)

FDA data resources