DISTOMETER
FDA 510(k) clearance K882575 · decided 1988-07-01
Clearance details
- K-number
- K882575
- Device name
- DISTOMETER
- Applicant
- Hagg-Streit Service, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-22
- Decision date
- 1988-07-01
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- HMM
- Device class
- 1
- Regulation number
- 886.1190
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, 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 |
|---|---|---|
| RULE, PUPILLARY (K873440) | Allegheny Plastics, Inc. | 1987-09-21 |
Recalls involving this device
No recalls on record reference this clearance.