ENDOTRACHEAL TUBE CHANGER
FDA premarket approval P800068/S001 · decided 1999-07-23
Approval details
- PMA number
- P800068
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTRACHEAL TUBE CHANGER
- Generic name
- Changer, tube, endotracheal
- Applicant
- Instrumentation Industries, Inc.
- Date received
- 1998-06-02
- Decision date
- 1999-07-23
- Days to decision
- 416 days
- Decision code
- APPR
- Product code
- LNZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Pittsburg, PA
- Statement
- Approval for the following changes: 1)Changes in manufacturing: a) new vendor for lumen extrusion; b) new vendor for imprinting the ink (reacted with a hardener) onto the tube changer; and c) eight additional sizes and three additional colors. 2) Change in labeling: a) change in the indications for use statement to reflect the eight new models; and b) revisions in the instructions for use.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NS 120P-TRS Airway Pressure Gauge (K180510) | Instrumentation Industries, Inc. | 2019-05-01 |
| RTC 26-C Inline Aerosol Adapter (K162753) | Instrumentation Industries, Inc. | 2017-02-28 |
| PILOT TUBE REPAIR KIT (K113644) | Instrumentation Industries, Inc. | 2012-01-26 |
| ENDOTRACHEAL TUBE CHANGERS (K102127) | Instrumentation Industries, Inc. | 2010-08-27 |
| RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (K101857) | Instrumentation Industries, Inc. | 2010-07-22 |
| RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC (K091111) | Instrumentation Industries, Inc. | 2009-12-02 |
| NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (K081778) | Instrumentation Industries, Inc. | 2008-09-12 |
| NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (K081693) | Instrumentation Industries, Inc. | 2008-09-11 |