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510(k) K861030

LABOR-DELIVERY STRETCH/BED by Adel Medical , Ltd. — Product Code KNC

K861030 is an FDA 510(k) premarket notification submitted by Adel Medical , Ltd. for the device "LABOR-DELIVERY STRETCH/BED". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Adel Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 18, 1986
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 Adel Medical , Ltd.

  • K890476 — ADEL - MODEL 986 INFANT WARMER (June 16, 1989)
  • K874610 — ADEL MODEL 2100 BIRTHING BED (January 21, 1988)
  • K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER (May 11, 1987)
  • K860020 — MINOR SURGERY LIGHT MODEL 2112 (January 24, 1986)
  • K833321 — LABOR/DELIVERY/RECOVERY BED LDR-600 (November 14, 1983)
  • K810886 — ADEL MEDICAL BIRTHING BED, #LD-500 (April 23, 1981)
  • K801622 — ADEL MEDICAL BIRTHING BED, MOD. LD-400 (August 14, 1980)

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