AIRWAY SUPPORT SYSTEM / AIRPORT

Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number

K131506

Device Name

AIRWAY SUPPORT SYSTEM / AIRPORT

Applicant

ABEON MEDICAL CORPORATION

8000 katherine boulevard

brecksville,
OH
44141

Applicant Contact

allison slaga

Correspondent

ABEON MEDICAL CORPORATION

8000 katherine boulevard

brecksville,
OH
44141

Correspodent Contact

allison slaga

Regulation Number

868.1400

Classification Product Code

CCK

Date Received

05/24/2013

Decision Date

03/06/2014

Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type

Traditional

Reviewed by Third Party

No

Combination Product

No