Data / Medical devices / United States / Glottal Ent., Inc.
Glottal Ent., Inc.: FDA-registered device maker in Syracuse, NY, United States, 1 510(k) clearance
Glottal Ent., Inc. is registered with the FDA (registration 1319182) in Syracuse, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 28, 1990. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1319182
- Address
- 1201 E. Fayette ST., Syracuse, NY, United States, 13210
- Owner or operator
- GLOTTAL ENTERPRISES, INC. (1319182)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 17, 1992
- Registered through
- 2026
- Brand names listed
- EG2, PG-20, PG-60
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electroglottograph | KLX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Miniature Pressure | IKE | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 1990 | K901609 | ELECTROGLOTTOGRAPH | KLX | Substantially Equivalent | Glottal Ent., Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 28, 1990. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.