Clearance Summary
JDM SP2 SENSOR received FDA 510(k) clearance under submission number K873806, sponsored by Jd Monitoring C/O Mackler, Cooper and Gibbs. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-12-08.
- Submission: K873806
- Applicant / Sponsor: Jd Monitoring C/O Mackler, Cooper and Gibbs
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 1987-12-08
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.