The following data is part of a premarket notification filed by Glottal Ent., Inc. with the FDA for Electroglottograph.
| Device ID | K901609 |
| 510k Number | K901609 |
| Device Name: | ELECTROGLOTTOGRAPH |
| Classification | Electroglottograph |
| Applicant | GLOTTAL ENT., INC. SUITE 400 1150 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | & Jaworski |
| Correspondent | & Jaworski GLOTTAL ENT., INC. SUITE 400 1150 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | KLX |
| CFR Regulation Number | 874.1325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1990-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011116905 | K901609 | 000 |