510(k) K101892
K101892 is an FDA 510(k) premarket notification submitted by Heine Optotechnik GmbH & Co. KG for the device "HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Heine Optotechnik GmbH & Co. KG has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2010
- Date Received
- July 7, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Pressure Cuff
- Device Class
- Class II
- Regulation Number
- 870.1120
- Review Panel
- CV
- Submission Type
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.