Medical Device Manufacturer · US , Austin , TX

International Biomedical, Ltd.

6 submissions · 6 cleared · Since 2008

Total

Cleared

Denied

International Biomedical, Ltd. — FDA 510(k) Submissions

International Biomedical, Ltd. has submitted 6 FDA 510(k) premarket notifications since 2008, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Incubator, Neonatal Transport, Apparatus, Nitric Oxide Delivery . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

K103523 · FPL Incubator, Neonatal... · General Hospital

May 2011 161d

A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX

K103525 · FPL Incubator, Neonatal... · General Hospital

May 2011 161d

VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

K103524 · FPL Incubator, Neonatal... · General Hospital

Apr 2011 135d

AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX