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510(k) K884619

PACH-PEN CALCULATOR by Oculab, Inc. — Product Code DXG

K884619 is an FDA 510(k) premarket notification submitted by Oculab, Inc. for the device "PACH-PEN CALCULATOR". The FDA issued a decision of Substantially Equivalent on February 2, 1989. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Oculab, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1989
Date Received
November 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Oculab, Inc.

  • K882750 — OCU-FILM TIP COVER (August 4, 1988)
  • K862016 — PACH-PEN SURGICAL DRAPE (June 4, 1986)
  • K860205 — BIO-PEN CALCULATOR (April 24, 1986)
  • K860061 — OCULAB BIOMETRICPEN (March 10, 1986)
  • K860062 — OCULAB PACHPEN (March 10, 1986)
  • K852774 — OCULAB TONOPEN (August 20, 1985)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)

FDA data resources