SIMS INTERTECH HYPERINFLATION BAG SYSTEM
FDA 510(k) clearance K952214 · decided 1995-06-08
Clearance details
- K-number
- K952214
- Device name
- SIMS INTERTECH HYPERINFLATION BAG SYSTEM
- Applicant
- Intertech Resources, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-11
- Decision date
- 1995-06-08
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- NHK
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fort Myers, FL, 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 |
|---|---|---|
| VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (K092687) | A Plus Medical | 2009-11-23 |
| MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM (K020281) | Ventlab Corp. | 2002-02-11 |
| VENTLAB HYPERINFLATION BAG SYSTEM (K013308) | Ventlab Corp. | 2001-12-20 |
| MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (K001714) | Mercury Medical | 2000-11-03 |
| SIMS HYPERINFLATION BAG SYSTEM (K970785) | Sims | 1997-06-13 |
| HYPER-INFLATION BAG (K942571) | Med-Plastics Intl., Inc. | 1994-06-10 |
| HYPERINFLATION BAG SYSTEM (K940255) | Nutec, Inc. | 1994-02-17 |
| INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (K894612) | Intertech Resources, Inc. | 1989-09-08 |
| DISP. HYPERINFLATION BAG SYSTEM (K813317) | Intec Medical, Inc. | 1982-03-12 |
Recalls involving this device
No recalls on record reference this clearance.