The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Laser Alignment Tool.
| Device ID | K943381 |
| 510k Number | K943381 |
| Device Name: | LASER ALIGNMENT TOOL |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-08-09 |
| Summary: | summary |