NUCLEAR STRESS TABLE (NST-1)
FDA 510(k) clearance K800892 · decided 1980-05-14
Clearance details
- K-number
- K800892
- Device name
- NUCLEAR STRESS TABLE (NST-1)
- Applicant
- Technicare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-18
- Decision date
- 1980-05-14
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- ISD
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S015) | Technicare Corp. | 1988-07-14 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S014) | Technicare Corp. | 1987-08-26 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S011) | Technicare Corp. | 1986-11-14 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S012) | Technicare Corp. | 1986-11-05 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S013) | Technicare Corp. | 1986-10-22 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S009) | Technicare Corp. | 1986-10-01 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S007) | Technicare Corp. | 1986-10-01 |
| TESLACON(TM) NMR IMAGING SYSTEM (P830051/S010) | Technicare Corp. | 1986-10-01 |