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510(k) K875123

ORCEPAD by Alton Dean Medical, Inc. — Product Code HDD

K875123 is an FDA 510(k) premarket notification submitted by Alton Dean Medical, Inc. for the device "ORCEPAD". The FDA issued a decision of Substantially Equivalent on June 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
December 15, 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 for product code HDD

  • K950889 — ADEL 5000 (October 16, 1995)
  • K914309 — THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES (April 20, 1992)
  • K874610 — ADEL MODEL 2100 BIRTHING BED (January 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