SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
FDA 510(k) clearance K892121 · decided 1989-06-16
Clearance details
- K-number
- K892121
- Device name
- SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
- Applicant
- Biocom Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-31
- Decision date
- 1989-06-16
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- BZC
- Device class
- 2
- Regulation number
- 868.1880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Puyallup, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.