Submission Details
| 510(k) Number | K970812 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 1997 |
| Decision Date | August 05, 1997 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
PM 2002 CC PROLINE
Aug 1997
Decision
153d
Days
Class 2
Risk
About This 510(k) Submission
K970812 is an FDA 510(k) clearance for the PM 2002 CC PROLINE, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on August 5, 1997, 153 days after receiving the submission on March 5, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
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