Product code IXO
- Device name
- Synchronizer, Ecg / Respirator, Radiographic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1970
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | Radiation Measurements, Inc. | 1986-05-07 |
| K811587 | SIEMENS ANGIOTRON | Siemens Corp. | 1981-07-10 |
| K810588 | SYNCHRONIZER #208 | Brattle Instrument Corp. | 1981-04-10 |
| K791959 | POST EXTRA SYSTOLIC POSTENTLATOR | Medrad, Inc. | 1980-01-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00855170007447 | Pneumograph - Non-Metallic 98in. Tubing | LAFAYETTE INSTRUMENT COMPANY, INC. | 2025-08-14 |
| 00855170007140 | PNEUMO NONMETALIC 10' LATEX FREE | LAFAYETTE INSTRUMENT COMPANY, INC. | 2023-06-12 |
| 00855170007157 | PED NONMETAL PNEUMO 10' LATEX FREE | LAFAYETTE INSTRUMENT COMPANY, INC. | 2023-06-12 |
| 00855170007164 | NONMETAL PNEUMO 12' LUER LATEX FREE | LAFAYETTE INSTRUMENT COMPANY, INC. | 2023-06-12 |
| 00855170007195 | "PNEUMO NONMETALIC 89"" LATEX FREE" | LAFAYETTE INSTRUMENT COMPANY, INC. | 2023-06-12 |
| 00855170007201 | "PED NONMETAL PNEUMO 89"" LATEX FREE" | LAFAYETTE INSTRUMENT COMPANY, INC. | 2023-06-12 |
| 00855170007300 | Pneumograph - Non-Metallic 14ft. Tubing | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007348 | Pneumograph Nonmetalic 135cm Strap | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007331 | "Pediatric Pneumograph - Non-Metallic w/89"" Tubing" | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007324 | Pneumograph - Non-Metallic 89in. Tubing | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007317 | Pneumograph - Non-Metallic 18' w/Connector | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007294 | Pneumograph - Non-Metallic 12' w/Connector | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007287 | Pediatric Pneumograph - Non-Metallic w/10' Tubing | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00855170007270 | Pneumograph - Non-Metallic 10ft. Tubing | LAFAYETTE INSTRUMENT COMPANY, INC. | 2021-08-31 |
| 00840682146395 | NA | GE Medical Systems, L.L.C. | 2019-09-20 |
| 00816396020788 | CTM-400 | IVY BIOMEDICAL SYSTEMS, INC. | 2016-11-10 |
| 00816396020795 | CTM-400 | IVY BIOMEDICAL SYSTEMS, INC. | 2016-11-10 |
| 00816396020801 | CTM-400 | IVY BIOMEDICAL SYSTEMS, INC. | 2016-11-10 |
| 00816396022171 | CTM-400 | IVY BIOMEDICAL SYSTEMS, INC. | 2016-11-10 |