| Device Type ID | 27 |
| Device Name | Calculator, Predicted Values, Pulmonary Function |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BTY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 27 |
| Device | Calculator, Predicted Values, Pulmonary Function |
| Product Code | BTY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| CFR Regulation Number | 868.1890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NDD MEDIZITECHNIK AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHAPE MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Calibration Problem | 8 |
Device Operational Issue | 3 |
Incorrect Software Programming Calculations | 2 |
Failure To Calibrate | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Break | 1 |
Temperature Problem | 1 |
Computer Software Problem | 1 |
Low Test Results | 1 |
Failure To Power Up | 1 |
Application Program Problem | 1 |
Patient Data Problem | 1 |
Application Program Problem: Dose Calculation Error | 1 |
Connection Problem | 1 |
Electrical Power Problem | 1 |
Sparking | 1 |
Gas Leak | 1 |
Programming Issue | 1 |
| Total Device Problems | 30 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Shape Medical Systems, Inc | II | Feb-05-2015 |
| 2 | Shape Medical Systems, Inc | II | Jul-14-2014 |