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510(k) K850538

BED SENTRY, MODEL 50U by Metatech Corp. — Product Code KPN

K850538 is an FDA 510(k) premarket notification submitted by Metatech Corp. for the device "BED SENTRY, MODEL 50U". The FDA issued a decision of Substantially Equivalent on April 3, 1985. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Metatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1985
Date Received
February 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type

Other clearances by Metatech Corp.

  • K924314 — MOBILE STANDING FRAME (February 12, 1993)
  • K915370 — COPPER VAPOR LASER SYSTEM (February 7, 1992)
  • K903883 — VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES (September 19, 1990)
  • K890865 — HEXASCAN SCANNER HANDPIECE (March 24, 1989)
  • K883541 — METALASER VASCULASE (November 4, 1988)
  • K883881 — MODIFIED MODEL 2001 FIBER OPTICS CATHETER (October 27, 1988)
  • K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (September 22, 1988)
  • K882552 — METATECH ROBINSON BOLT ACCESSORY (September 8, 1988)
  • K882367 — METATECH MICROCLIP APPLICATOR (August 25, 1988)
  • K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (July 18, 1988)

Other clearances for product code KPN

  • K130951 — SIM (August 22, 2013)
  • K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M (January 8, 1998)
  • K971855 — POTTY PAL AND FOREVER-DRY (August 18, 1997)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)
  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)

FDA data resources