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510(k) K830221

BEDSIDE N.P.T. 9900 - PRINTER 9800 by Browne Medical, Inc. — Product Code LIL

K830221 is an FDA 510(k) premarket notification submitted by Browne Medical, Inc. for the device "BEDSIDE N.P.T. 9900 - PRINTER 9800". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code LIL (Monitor, Penile Tumescence), a Class U device. Browne Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
January 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Penile Tumescence
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Browne Medical, Inc.

  • K851483 — UROBEI STRESS INCONTINENCE MONITOR (August 7, 1985)
  • K834503 — PROFILE URODYNAMIC MONITORING SYS (February 21, 1984)
  • K833043 — UROMETER (February 4, 1984)

Other clearances for product code LIL

  • K061676 — RIGIDOMETER, MODEL DIR-4U (December 27, 2006)
  • K062042 — PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (September 6, 2006)
  • K052929 — PREFTEST PROFESSIONAL SUITE (April 26, 2006)
  • K033126 — MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (October 29, 2003)
  • K000194 — DIGITAL INFLECTION RIGIDOMETER (DIR) (April 10, 2000)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K980627 — NEVA SYSTEM (April 7, 1998)
  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)

FDA data resources