NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
FDA 510(k) clearance K081778 · decided 2008-09-12
Clearance details
- K-number
- K081778
- Device name
- NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-23
- Decision date
- 2008-09-12
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- CAP
- Device class
- 2
- Regulation number
- 868.2600
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bethel Park, PA, 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 |
|---|---|---|
| SINGLE USE MANOMETER (K201666) | Flexicare Medical Limited. | 2020-11-13 |
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| NS 120P-TRS Airway Pressure Gauge (K180510) | Instrumentation Industries, Inc. | 2019-05-01 |
| NAPA LP-15 Airway Pressure Monitor (K172284) | Drw Medical, LLC | 2018-02-09 |
| VORTRAN Manometer (K153733) | Vortran Medical Technology 1, Inc. | 2016-09-16 |
| Disposable Pressure Manometer (DPM) (K143148) | Westmed, Inc. | 2015-08-11 |
| DISPOSABLE PRESSURE MANOMETER (K140370) | Besmed Health Business Corp | 2014-06-19 |
| GIO DIGITAL PRESSURE GUAGES (K122627) | Galemed Corp. | 2013-08-22 |
| MANOMETER (K122077) | Intersurgical, Inc. | 2013-01-10 |
| VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118) | Ventlab Corp. | 2012-05-24 |
| VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC (K103639) | Vortran Medical Technology 1, Inc. | 2011-09-15 |
| PRESSURE MANOMETER (K110119) | Neoforce Group, Inc. | 2011-06-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE CHANGERS (P800068/S002) | Instrumentation Industries, Inc. | 1999-11-04 |
| ENDOTRACHEAL TUBE CHANGER (P800068/S001) | Instrumentation Industries, Inc. | 1999-07-23 |
| ENDOTRACHEAL TUBE CHANGER (P800068) | Instrumentation Industries, Inc. | 1981-07-21 |