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510(k) K860205

BIO-PEN CALCULATOR by Oculab, Inc. — Product Code LQB

K860205 is an FDA 510(k) premarket notification submitted by Oculab, Inc. for the device "BIO-PEN CALCULATOR". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code LQB (Medical Computers And Software For Ophthalmic Use), a Class III device. Oculab, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
January 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medical Computers And Software For Ophthalmic Use
Device Class
Class III
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Oculab, Inc.

  • K884619 — PACH-PEN CALCULATOR (February 2, 1989)
  • K882750 — OCU-FILM TIP COVER (August 4, 1988)
  • K862016 — PACH-PEN SURGICAL DRAPE (June 4, 1986)
  • K860061 — OCULAB BIOMETRICPEN (March 10, 1986)
  • K860062 — OCULAB PACHPEN (March 10, 1986)
  • K852774 — OCULAB TONOPEN (August 20, 1985)

Other clearances for product code LQB

  • K922590 — BIO-PEN SRK II CALCULATOR (August 3, 1993)

FDA data resources