The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for Rls 9100 Rhino-laryngeal Stroboscope.
| Device ID | K921184 |
| 510k Number | K921184 |
| Device Name: | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE |
| Classification | Laryngostroboscope |
| Applicant | KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook, NJ 07058 |
| Contact | William Harbeson |
| Correspondent | William Harbeson KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook, NJ 07058 |
| Product Code | EQL |
| CFR Regulation Number | 874.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242177 | K921184 | 000 |
| 04961333240593 | K921184 | 000 |
| 04961333240609 | K921184 | 000 |
| 04961333240616 | K921184 | 000 |
| 04961333240623 | K921184 | 000 |
| 04961333240630 | K921184 | 000 |
| 04961333240647 | K921184 | 000 |
| 04961333240685 | K921184 | 000 |
| 04961333241897 | K921184 | 000 |
| 04961333241903 | K921184 | 000 |
| 04961333242009 | K921184 | 000 |
| 04961333242160 | K921184 | 000 |
| 04961333230594 | K921184 | 000 |