Medical Device Manufacturer · US , Royersford , PA

Amici, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1987

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amici, Inc. Radiology ✕

5 devices

1-5 of 5

Cleared Jan 14, 1991

AMICI XENON ADMINISTRATION SET

Radiology · 152d

Cleared Jan 14, 1991

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION

Radiology · 152d

Cleared Oct 03, 1990

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

Radiology · 49d

Cleared Feb 12, 1988

AMICI KRYPTON ADMINISTRATION SYSTEM*

Radiology · 200d

Cleared Mar 03, 1987

AMICI XENON REBREATHING SYSTEM*

Radiology · 63d