The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for Electroglottograph.
| Device ID | K990240 |
| 510k Number | K990240 |
| Device Name: | ELECTROGLOTTOGRAPH |
| Classification | Electroglottograph |
| Applicant | KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
| Contact | William D Harbeson |
| Correspondent | William D Harbeson KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
| Product Code | KLX |
| CFR Regulation Number | 874.1325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333230488 | K990240 | 000 |
| 04961333230419 | K990240 | 000 |
| 04961333229888 | K990240 | 000 |
| 04961333229796 | K990240 | 000 |