510(k) K921331
K921331 is an FDA 510(k) premarket notification submitted by Health Watch, Inc. for the device "CAMBRIDGE PC/GXT STRESS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 11, 1992. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Health Watch, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1992
- Date Received
- March 19, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type