ID. STORE (RELEASE 2.0)
FDA 510(k) clearance K973413 · decided 1997-11-25
Clearance details
- K-number
- K973413
- Device name
- ID. STORE (RELEASE 2.0)
- Applicant
- I.S.G. Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-09
- Decision date
- 1997-11-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mississauga Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.