SP 4
FDA 510(k) clearance K853541 · decided 1986-03-28
Clearance details
- K-number
- K853541
- Device name
- SP 4
- Applicant
- Robert Bosch Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1985-08-26
- Decision date
- 1986-03-28
- Days to decision
- 214 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- St. James, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.