Home / 510(k) Clearances / K874610

510(k) K874610

ADEL MODEL 2100 BIRTHING BED by Adel Medical , Ltd. — Product Code HDD

K874610 is an FDA 510(k) premarket notification submitted by Adel Medical , Ltd. for the device "ADEL MODEL 2100 BIRTHING BED". The FDA issued a decision of Substantially Equivalent on January 21, 1988. The device falls under product code HDD (Table, Obstetrical, Ac-Powered (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
January 21, 1988
Date Received
November 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetrical, Ac-Powered (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)
  • K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER (May 11, 1987)
  • K861030 — LABOR-DELIVERY STRETCH/BED (April 23, 1986)
  • 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 HDD

  • K950889 — ADEL 5000 (October 16, 1995)
  • K914309 — THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES (April 20, 1992)
  • K875123 — ORCEPAD (June 21, 1988)
  • K810886 — ADEL MEDICAL BIRTHING BED, #LD-500 (April 23, 1981)
  • K771942 — TILT 10, CATALOG #S-2600 (October 27, 1977)
  • K770438 — CART, PROCEDURES (July 1, 1977)

FDA data resources