K780628 is an FDA 510(k) clearance for the HALOGEN EXAM. LITE #48400. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 6, 1978, 50 days after receiving the submission on April 17, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.
| 510(k) Number | K780628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1978 |
| Decision Date | June 06, 1978 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KZF — Device, Medical Examination, Ac Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6320 |