510(k) K831955
K831955 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "HR 100T". The FDA issued a decision of Substantially Equivalent on Aug 11, 1983. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Thought Technology , Ltd. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 1983
- Date Received
- Jun 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type
- 510(k)