K874254 is an FDA 510(k) clearance for the ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS. This device is classified as a Laser, Neodymium:yag, Pulmonary Surgery (Class II - Special Controls, product code LLO).
Submitted by Minnesota Laser Corp. (Roseville, US). The FDA issued a Cleared decision on March 4, 1988, 136 days after receiving the submission on October 20, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K874254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1987 |
| Decision Date | March 04, 1988 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | LLO — Laser, Neodymium:yag, Pulmonary Surgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |