The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Guava Ii.
| Device ID | K122632 |
| 510k Number | K122632 |
| Device Name: | GUAVA II |
| Classification | Electrocardiograph |
| Applicant | CARDIOCOMM SOLUTIONS, INC. 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Contact | Jonathan Ward |
| Correspondent | Jonathan Ward CARDIOCOMM SOLUTIONS, INC. 445 APOLLO BEACH BLVD. Apollo Beach, FL 33572 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2014-02-11 |
| Summary: | summary |