The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Belmont Autopan-panoramic 098 Cephalometric-radiog.
Device ID | K844554 |
510k Number | K844554 |
Device Name: | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG |
Classification | Film, Radiographic |
Applicant | BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
Contact | John M Gardella |
Correspondent | John M Gardella BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
Product Code | IWZ |
CFR Regulation Number | 892.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-21 |
Decision Date | 1985-02-21 |