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510(k) K925530

INSTRUMENT WARMER by Superior Healthcare Group, Inc. — Product Code FMS

K925530 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "INSTRUMENT WARMER". The FDA issued a decision of Substantially Equivalent on June 18, 1993. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1993
Date Received
November 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Pediatric Open Hospital
Device Class
Class II
Regulation Number
880.5140
Review Panel
HO
Submission Type

Other clearances by Superior Healthcare Group, Inc.

  • K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR (March 15, 1993)
  • K905755 — NON-STERILE PATIENT EXAMINATION GLOVES (March 8, 1991)
  • K903347 — SODIUM CHLORIDE SOLUTION (December 13, 1990)
  • K904216 — STERILE WATER SOLUTION CATALOG # 10000 (November 16, 1990)
  • K903340 — STERILE URETHRAL CATHETER PROCEDURE KITS (October 4, 1990)
  • K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (November 13, 1989)
  • K894676 — STERILE LATEX EXAM GLOVES (August 17, 1989)
  • K891445 — LATEX EXAMINATION GLOVES (August 9, 1989)
  • K892426 — NO. 86500 - ENDOSCOPIC JET WASHER (June 22, 1989)
  • K885339 — FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT (March 1, 1989)

Other clearances for product code FMS

  • K970334 — NATURE'S CRADLE (April 25, 1997)
  • K963210 — VAIL 100 PEDIATRIC CRIB (November 13, 1996)
  • K960747 — NATURE'S CRADLE MODEL C1500 (May 22, 1996)
  • K960012 — STRYKER ADEL BASSINET (March 25, 1996)
  • K951024 — NATURE'S CRADLE (June 5, 1995)
  • K950059 — MC INFANT CARE UNIE #PP30 (February 10, 1995)
  • K950051 — BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (February 10, 1995)
  • K950058 — MC HEALTHCARE #CH31 CHILD'S CRIB (February 10, 1995)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)
  • K925949 — PEDICRAGT BASSINET (April 20, 1993)

FDA data resources