The following data is part of a premarket notification filed by C.l. Mcintosh & Assoc., Inc. with the FDA for Nicas 2001 Noninvasive Cardio-respiratory System.
| Device ID | K942227 |
| 510k Number | K942227 |
| Device Name: | NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | C.L. MCINTOSH & ASSOC., INC. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Contact | Nancy F Teague |
| Correspondent | Nancy F Teague C.L. MCINTOSH & ASSOC., INC. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-06 |
| Decision Date | 1996-06-28 |
| Summary: | summary |