Max-1 R113P90

by Maxtec, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817770020004 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK972992	Date30 Mar 1998Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00817770020004
FDA 510(k) database 510(k) number K972992

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Max-1
Generic name: Respiratory oxygen sensor
Model / reference: R113P90

Primary DI / UDI-DI: 00817770020004
510(k) Number: K972992
FDA product code: CCL
GMDN term: Respiratory oxygen sensor

Device class: Class II
Regulation number: 868.1720
GUDID distribution status: In Commercial Distribution

Other devices from Maxtec, Inc.

Korr Connections Max-14 Oxygen Sensor

Class IIa
Smart Stack IV Pole Stand & Smart Stack Equipment Stand

Class I
2 in 1 Muffled Adapter, Molded

Class I
2-in-1 Muffled Adapter

Class I
Flowmeter 2-26 LPM Thorpe

Class I
Flowmeter 0-15 LPM

Class I

See all devices from Maxtec, Inc. →

Properties

Serial number

Other properties (14)

Supplied sterile: No
Sterilise before use: No
Single use: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Lot / batch number: No
Expiration date: No
Manufacturing date: No