510(k) K822522
K822522 is an FDA 510(k) premarket notification submitted by Life Sciences Manufacturing, Inc. for the device "CUTANEOUS PRESSURE PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Life Sciences Manufacturing, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1982
- Date Received
- August 23, 1982
- 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