K943381 is an FDA 510(k) clearance for the LASER ALIGNMENT TOOL. This device is classified as a Monitor, Patient Position, Light-beam (Class I - General Controls, product code IWE).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on August 9, 1994, 27 days after receiving the submission on July 13, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5780.
| 510(k) Number | K943381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | August 09, 1994 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWE — Monitor, Patient Position, Light-beam |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.5780 |