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510(k) K904127

A2J TELEMETER by A2j, Inc. — Product Code IWE

K904127 is an FDA 510(k) premarket notification submitted by A2j, Inc. for the device "A2J TELEMETER". The FDA issued a decision of Substantially Equivalent on January 4, 1991. The device falls under product code IWE (Monitor, Patient Position, Light-Beam), a Class I device regulated under 21 CFR 892.5780. A2j, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1991
Date Received
August 29, 1990
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 A2j, Inc.

  • K931974 — AZ 92 (October 8, 1993)
  • K881591 — A2J MZ 45 LASER LIGHT FOR POSITIONING (April 27, 1988)
  • K880981 — A2J MZ 44 B TYPE (April 22, 1988)

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