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510(k) K801541

WALL MOUNTED LASER POSITIONING DEVICE by Advantage Medical Systems, Inc. — Product Code IWE

K801541 is an FDA 510(k) premarket notification submitted by Advantage Medical Systems, Inc. for the device "WALL MOUNTED LASER POSITIONING DEVICE". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. Advantage Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

Other clearances by Advantage Medical Systems, Inc.

  • K873957 — NON-CORING HUBER TYPE NEEDLES (October 23, 1987)
  • K873290 — LACERATION AND INSTRUMENT TRAYS (September 24, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K842462 — HOLTER SCREENING MONITOR HS-221 (September 11, 1984)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)

Other clearances for product code IWE

  • K152303 — CT Sim Laser System (September 11, 2015)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954414 — CENTRALITE BACKPOINTER (October 23, 1995)
  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)

FDA data resources