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Max-16LF R114P75

by Maxtec, Inc.

Ref R114P75

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972992

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081777002MAXSENKOHK3 Basic UDI-DI 00817770021407UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770021407 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972992 Date30 Mar 1998DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MAX-16LF Oxygen Sensor EUDAMED
Max-16LF GUDID
Generic name
Respiratory oxygen sensor
Device name
MAX KOH Oxygen Sensor
Model / reference
R114P75
Primary DI / UDI-DI
00817770021407
Basic UDI-DI
081777002MAXSENKOHK3
Direct marketing DI
00817770021407
510(k) Number
FDA product code
CCL
EMDN code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN term
Respiratory oxygen sensor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1720
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Respiratory oxygen sensor

Cleared under the same submission (K972992)

Show all (12)

Other devices from Maxtec, Inc.

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Properties

  • Prescription use
  • Lot / batch number
  • Serial number

Other properties (22)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No
  • Manufacturing date: No