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510(k) K914544

BD6000 THE OPTIMA & BD5000 BIRTHING BED by Lic Care, Inc. — Product Code KNC

K914544 is an FDA 510(k) premarket notification submitted by Lic Care, Inc. for the device "BD6000 THE OPTIMA & BD5000 BIRTHING BED". The FDA issued a decision of Substantially Equivalent on November 24, 1993. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Lic Care, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1993
Date Received
October 10, 1991
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 by Lic Care, Inc.

  • K914543 — ST5500 UNIVERSAL CARE STRETCHER (January 8, 1992)

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)
  • 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)
  • K861030 — LABOR-DELIVERY STRETCH/BED (April 23, 1986)

FDA data resources