Philips Angiopro
FDA 510(k) K911888 · Philips Medical Systems North America, Inc.
510(k) numberK911888
Submission
- Device name
- Philips Angiopro
- Applicant
- Philips Medical Systems North America, Inc.
Shelton, CT, US - Received
- April 29, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K904103 | Sep 90IZP · Traditional | Elema-Schonander, Inc. | 11/20/1990SE |
| K874451 | Omniplane 200 Film Changer SystemIZP · Traditional | Medrad, Inc. | 02/11/1988SE |
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| K842903 | Sep Programmer for Puck U & Ud FilmchangIZP · Traditional | Elema-Schonander, Inc. | 08/21/1984SE |
| K841732 | Liebel-Flarsheim Afc 1000 X-Ray FilmIZP · Traditional | Sybron Corp. | 06/05/1984SE |
| K841649 | Maximax - 4IZP · Traditional | Cgr Medical Corp. | 06/05/1984SE |
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Questions and answers
When was Philips Angiopro cleared by the FDA?
Philips Angiopro (K911888) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 169 days after the submission was received.
What is the product code of K911888?
The FDA product code is IZP – Programmer, Changer, Film/Cassette, Radiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1870.