Nordix Inc Rechargeable Battery Part Number 2116

FDA 510(k) K013133 · Nordix, Inc.

Substantially Equivalent

510(k) numberK013133

Submission

Device name
Nordix Inc Rechargeable Battery Part Number 2116
Applicant
Nordix, Inc.
Phoenix, AZ, US
Received
September 19, 2001
Decision date
November 13, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MOQ – Battery, Replacement, Rechargeable
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code MOQ

510(k)DeviceApplicantDecision
K081713Vertebral Access System by VidacareMOQ · Traditional Vidacare Corporation11/21/2008SE
K980224Alexander Manufacturing Co. Rechargeable Battery Part Number MS822MOQ · Traditional Alexander Mfg. Co.04/02/1998SE

Questions and answers

When was Nordix Inc Rechargeable Battery Part Number 2116 cleared by the FDA?

Nordix Inc Rechargeable Battery Part Number 2116 (K013133) received a 510(k) decision of Substantially Equivalent on November 13, 2001, 55 days after the submission was received.

What is the product code of K013133?

The FDA product code is MOQ – Battery, Replacement, Rechargeable, a Class I (low risk) device regulated under 21 CFR 878.4820.