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Advanced Markus

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 2 variants

Advanced Markus (TN34045) is an ionization chamber radiation measuring probe (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, cleared under FDA 510(k) K961208 on 17 Jun 1996 and listed in FDA GUDID since 27 Apr 2017 (UDI-DI EPTWTN340450), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K961208

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPTWTN340450 UDI-DI Date27 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK961208 Date17 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K961208 decided 17 Jun 1996 Active
  • FDA GUDID UDI-DI EPTWTN340450 listed 27 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K961208
  2. Listed FDA GUDID EPTWTN340450

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ionization chamber radiation measuring probe
Model / Ref / Catalog
Advanced Markus electron chamber 0.02 cm³, TN34045
Primary DI / UDI-DI
EPTWTN340450
510(k) Number
FDA product code
IYE
GMDN term
Ionization chamber radiation measuring probe
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ionization chamber radiation measuring probe

Cleared under the same submission (K961208)

and 8 more cleared under K961208

Similar devices in this category

Other devices filed under Ionization chamber radiation measuring probe.

Other devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

See all devices from PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)