K951804 is an FDA 510(k) clearance for the KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 5, 1995, 47 days after receiving the submission on April 19, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K951804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1995 |
| Decision Date | June 05, 1995 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5540 |