MODEL 2100 FETAL MONITOR
FDA 510(k) clearance K837102 · decided 1983-03-14
Clearance details
- K-number
- K837102
- Device name
- MODEL 2100 FETAL MONITOR
- Applicant
- Huntleigh Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-07
- Decision date
- 1983-03-14
- Days to decision
- 66 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Luton Beds Lu1 1uu, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.