PDS COMPUTER UNIT/VIDEO TERMINAL
FDA 510(k) clearance K801761 · decided 1980-08-20
Clearance details
- K-number
- K801761
- Device name
- PDS COMPUTER UNIT/VIDEO TERMINAL
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-28
- Decision date
- 1980-08-20
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- DRT
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733) | Neteera Technologies , Ltd. | 2024-02-09 |
| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| Neteera 130H/131H Vital Sign Monitoring Sensor (K212143) | Neteera Technologies , Ltd. | 2022-09-28 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |