510(k) K811909
K811909 is an FDA 510(k) premarket notification submitted by Michigan Instruments, Inc. for the device "CARDIOPULMUNARY RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on July 16, 1981. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Michigan Instruments, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1981
- Date Received
- July 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Cardiac, External
- Device Class
- Class II
- Regulation Number
- 870.5200
- Review Panel
- CV
- Submission Type