510(k) K933278
K933278 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Intermedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1995
- Date Received
- June 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Programmer, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3700
- Review Panel
- CV
- Submission Type