K911888 is an FDA 510(k) clearance for the PHILIPS ANGIOPRO. This device is classified as a Programmer, Changer, Film/cassette, Radiographic (Class II - Special Controls, product code IZP).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on October 15, 1991, 169 days after receiving the submission on April 29, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1870.
| 510(k) Number | K911888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1991 |
| Decision Date | October 15, 1991 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZP — Programmer, Changer, Film/cassette, Radiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1870 |