510(k) K772092
K772092 is an FDA 510(k) premarket notification submitted by Dynatech Research & Development Co. for the device "CHEST FLUID MONITOR". The FDA issued a decision of Substantially Equivalent on November 18, 1977. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Dynatech Research & Development Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1977
- Date Received
- November 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type