MODEL 835 SPOT FILM DEVICE
FDA 510(k) clearance K827858 · decided 1982-08-24
Clearance details
- K-number
- K827858
- Device name
- MODEL 835 SPOT FILM DEVICE
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-09
- Decision date
- 1982-08-24
- Days to decision
- 15 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Schenectady, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch General Electric Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |