510(k) K942227
K942227 is an FDA 510(k) premarket notification submitted by C.L. Mcintosh & Assoc., Inc. for the device "NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1996. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. C.L. Mcintosh & Assoc., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1996
- Date Received
- May 6, 1994
- 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