DIGITAL CRADLE
FDA 510(k) clearance K840463 · decided 1984-02-21
Clearance details
- K-number
- K840463
- Device name
- DIGITAL CRADLE
- Applicant
- Spectrum X-Ray Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-02
- Decision date
- 1984-02-21
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KXH
- Device class
- 1
- Regulation number
- 892.1830
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- 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 |
|---|---|---|
| PEDIATRIC POSITIONER PAD SET (K122174) | Ge Healthcare Coils (Usa Instruments, Inc.) | 2012-11-16 |
| OCTOROLL (K953246) | Octostop, Inc. | 1995-09-29 |
| VARIANT OF OCTOSTOP AND OCTOPAQUE (K930124) | Octostop, Inc. | 1994-02-09 |
| SPECTRUM DG-P7000 PEDIATRIC CRADLE (K933134) | Spectrum X-Ray Corp. | 1993-10-07 |
| ACCESSORY TO UNIVERSAL OCTOPAQUE (K930357) | Octostop, Inc. | 1993-07-13 |
| STRETCHER TABLE (K884292) | Fischer Imaging Corp. | 1989-03-31 |
| MAMM-AIRE (K863890) | Ar Custom Medical Products, Ltd. | 1986-10-14 |
| SPECTRUM PEDIATRIC CARDLE TABLE (K813561) | Spectrum X-Ray Corp. | 1982-01-29 |
Recalls involving this device
No recalls on record reference this clearance.