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510(k) K883818

MODIFIED REFLUX REDUCER by Physician Engineered Products, Inc. — Product Code FMS

K883818 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "MODIFIED REFLUX REDUCER". The FDA issued a decision of Substantially Equivalent on November 21, 1988. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Physician Engineered Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1988
Date Received
September 8, 1988
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 Physician Engineered Products, Inc.

  • K110550 — BRIGHT EMBRACE MODEL SBL60 (February 3, 2012)
  • K093618 — BILI-MIRROR MODEL BLM-1 (April 23, 2010)
  • K974830 — ULTRA BILI LIGHT (May 20, 1998)
  • K882291 — RETROFIT BABY FACE SHIELD (RFS) (June 20, 1988)
  • K882278 — RESUSCITATION BAG CONTROLLER (RBC) (June 16, 1988)
  • K873700 — INSTITUTIONAL BILI LIGHT (IBL) (December 11, 1987)
  • K850599 — HOME BILI LIGHTS-MODEL 100 (June 17, 1985)

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)
  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)

FDA data resources