EZ LOAD MODEL 30, ALL LEVEL COT
FDA 510(k) clearance K862441 · decided 1986-09-12
Clearance details
- K-number
- K862441
- Device name
- EZ LOAD MODEL 30, ALL LEVEL COT
- Applicant
- Ferno-Washington, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-26
- Decision date
- 1986-09-12
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- FPO
- Device class
- 2
- Regulation number
- 880.6910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wilmington, OH, US
- Third-party review
- No
- Expedited review
- No
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| EMERGENCY/ACCIDENT TROLLEY 550 (K946101) | Hogan & Hartson | 1995-02-07 |
| MODEL 792 CONVERGE, MODEL 793 VISION 2000 (K945431) | Hausted, Inc. | 1995-01-25 |
| MODEL 578 MOBILE SURGICAL STRETCHER (K943969) | Hausted, Inc. | 1995-01-25 |
| STRYKER POWERED STRETCHER (K942948) | Stryker Corp. | 1995-01-24 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565 recall (Z-0201-06) | Ferno-Washington Inc | 2005-11-26 |
| PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550. recall (Z-0202-06) | Ferno-Washington Inc | 2005-11-26 |