510(k) K800201
K800201 is an FDA 510(k) premarket notification submitted by Arzbaecher & Co. for the device "ESOPHAGEAL PILL-ELECTRODE". The FDA issued a decision of Substantially Equivalent on Feb 26, 1980. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Arzbaecher & Co. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 1980
- Date Received
- Jan 30, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type
- 510(k) Exempt