K944041 is an FDA 510(k) clearance for the PERSONAL HEARING SYSTEM, a I.v. Start Kit (Class II — Special Controls, product code LRS), submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on December 27, 1994, 131 days after receiving the submission on August 18, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K944041 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1994 |
| Decision Date | December 27, 1994 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LRS — I.v. Start Kit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |