The following data is part of a premarket notification filed by Polaroid Medical Corp. with the FDA for Polaroid Helios Laser Imager.
| Device ID | K912073 |
| 510k Number | K912073 |
| Device Name: | POLAROID HELIOS LASER IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | POLAROID MEDICAL CORP. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein POLAROID MEDICAL CORP. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1991-08-28 |