510(k) K953540
- Device
- EEE
- Applicant
- EDENTEC CORP.
- 510(k) number
- K953540
- Product code
- BYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-25
- Date received
- 1995-07-28
- Regulation
- 868.5375
- Classification name
- Condenser, Heat And Moisture (artificial Nose)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRIS HADLAND
- Address
- 10252 Valley View Rd. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 8021995
- 3012002722
- 1928237
- 3013576541
- 3014208300
- 3010220595
- 1832562
- 3010877292
- 3016634999
- 9611500
- 2031897
- 3010889742
- 3015142701
- 3002807267
- 3010515776
- 3003836856
- 3001313714
- 3016904853
- 8032044
- 3010957755
- 3031233007
- 8010042
- 3008693658
- 3021039857
- 3021244152
- 3005519819
- 3031369651
- 3004030908
- 3018094310
- 9710567
- 3014579161
- 3015495690
- 3011503227
- 3008311916
- 3005515211
- 3011137372
- 9617604
- 3013530359
- 3009887154
- 3012262567
- 3001104093
- 3006984712
- 3003862188
- 3030447506
- 3017937889
- 3014747754
- 2936999
- 9680661
- 9710644
- 3016458361
- 3004530184
- 3010321647
- 3006563173
- 3005998497
- 2028807
- 3003898360
- 3005855942
- 3004365956
- 3006534321
- 2183585
- 8030673
- 3010042047
- 8040412
- 3044994756
- 3004050971
- 3004905643
- 3003902312
- 3016674860
- 3006783791
- 3009171251
- 2529776
- 3004548776
- 3010131137
- 3004428458
- 8010485
- 3008567544
- 2025182
- 3010834934
- 3012521761
- 1220479
Source Documents#
Other 510(k) Records For Product Code BYD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | 1996-01-30 |
| K954194 | DISPOSABLE HME/FILTER | Engstrom Medical | 1995-10-20 |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | 1995-09-15 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | 1995-09-07 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | 1995-07-13 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 |
| K952036 | FLEXLIFE | Mallinckrodt Medical | 1995-06-08 |
Legacy Summary#
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FDA Review#
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