DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
FDA 510(k) clearance K924277 · decided 1994-12-07
Clearance details
- K-number
- K924277
- Device name
- DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
- Applicant
- Chalgren Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-25
- Decision date
- 1994-12-07
- Days to decision
- 834 days
- Clearance type
- Traditional
- Product code
- HLT
- Device class
- 2
- Regulation number
- 886.1640
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gilroy, CA, 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 |
|---|---|---|
| TOMEY PE-300 PORTABLE ERG (K921815) | Tomey Corporation USA | 1992-07-15 |
| PANORAMIC LOUPES - VARIOUS (K841293) | Keller Instruments, Inc. | 1984-05-09 |
| ORBIOGRAPH (K781543) | Sonometrics Systems, Inc. | 1978-10-24 |
Recalls involving this device
No recalls on record reference this clearance.