MODEL 412 ELECTROFLUIDIC MANOMETER
FDA 510(k) clearance K800222 · decided 1980-02-29
Clearance details
- K-number
- K800222
- Device name
- MODEL 412 ELECTROFLUIDIC MANOMETER
- Applicant
- Med-Tek Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-04
- Decision date
- 1980-02-29
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- DXW
- Device class
- 2
- Regulation number
- 870.1270
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (K972020) | Cas Medical Systems, Inc. | 1998-05-05 |
| NEWMED ABP-LITE (K955887) | Newmed Corp. | 1996-09-05 |
| MILLAR MIKRO-TIP CATHETER PHONOTRANS (K802830) | Millar Instruments, Inc. | 1980-12-10 |
| INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR (K800179) | Sphygmetrics, Inc. | 1980-02-11 |
Recalls involving this device
No recalls on record reference this clearance.