510(k) K781692
K781692 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "CALIBRATOR, DYNAMIC". The FDA issued a decision of Substantially Equivalent on November 29, 1978. The device falls under product code DXM (Densitometer), a Class II device regulated under 21 CFR 870.1450. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1978
- Date Received
- October 4, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer
- Device Class
- Class II
- Regulation Number
- 870.1450
- Review Panel
- CV
- Submission Type